Zacoldine Dosage

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Consists of Acetaminophen, chlorpheniramine maleate, K sulphoguaiacolate, phenylephrine

Dosage of Acetaminophen (Zacoldine) in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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General Dosing Information

Acetaminophen (Zacoldine) Injection may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral Acetaminophen (Zacoldine) and Acetaminophen (Zacoldine) Injection dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of Acetaminophen (Zacoldine) is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing Acetaminophen (Zacoldine). Exceeding the maximum mg/kg daily dose of Acetaminophen (Zacoldine) as described in Tables 1 to 3 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of Acetaminophen (Zacoldine) from all routes and from all sources does not exceed the maximum recommended dose.

Recommended

Dosage: Adults and Adolescents

Adults and adolescents weighing 50 kg and over: the recommended dosage of Acetaminophen (Zacoldine) Injection is 1,000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen (Zacoldine) Injection of 1,000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Zacoldine) of 4,000 mg per day (includes all routes of administration and all Acetaminophen (Zacoldine)-containing products including combination products).

Adults and adolescents weighing under 50 kg: the recommended dosage of Acetaminophen (Zacoldine) Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Zacoldine) Injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Zacoldine) of 75 mg/kg per day (includes all routes of administration and all Acetaminophen (Zacoldine)-containing products including combination products).

Table 1. Dosing for Adults and Adolescents
Age group

Dose given every 4 hours

Dose given every 6 hours

Maximum single dose

Maximum total daily dose of Acetaminophen (Zacoldine) (by all routes)

Adults and adolescents (13 years and older) weighing

≥ 50 kg

650 mg

1,000 mg

1,000 mg

4,000 mg in 24 hours

Adults and adolescents (13 years and older) weighing

< 50 kg

12.5 mg/kg

15 mg/kg

15 mg/kg

(up to 750 mg)

75 mg/kg in

24 hours

(up to 3,750 mg)

Recommended

Dosage: Children

Children 2 to 12 years of age: the recommended dosage of Acetaminophen (Zacoldine) Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Zacoldine) Injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Zacoldine) of 75 mg/kg per day.

Table 2. Dosing for Children
Age group

Dose given every 4 hours

Dose given every 6 hours

Maximum single dose

Maximum total daily dose of Acetaminophen (Zacoldine) (by all routes)

Children 2 to 12 years of age

12.5 mg/kg

15 mg/kg

15 mg/kg

(up to 750 mg)

75 mg/kg in

24 hours

(up to 3,750 mg)

Recommended Dosage for Treatment of Fever in Neonates and Infants

Neonates, including premature neonates born at ≥ 32 weeks gestational age, up to 28 days chronological age: the recommended dosage of Acetaminophen (Zacoldine) is 12.5 mg/kg every 6 hours, to a maximum daily dose of Acetaminophen (Zacoldine) of 50 mg/kg per day, with a minimum dosing interval of 6 hours.

Infants 29 days to 2 years of age: the recommended dosage of Acetaminophen (Zacoldine) is 15 mg/kg every 6 hours, to a maximum daily dose of Acetaminophen (Zacoldine) of 60 mg/kg per day, with a minimum dosing interval of 6 hours.

Table 3. Dosing for Treatment of Fever in Neonates and Infants
Age group

Dose given every 6 hours

Maximum total daily dose of Acetaminophen (Zacoldine) (by all routes)

Neonates (birth to 28 days)

12.5 mg/kg

50 mg/kg

Infants (29 days to 2 years)

15 mg/kg

60 mg/kg

Instructions for

Intravenous Administration

For adult and adolescent patients weighing ≥ 50 kg requiring 1,000 mg doses of Acetaminophen (Zacoldine) Injection, administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen (Zacoldine) Injection may be administered without further dilution. Examine the container contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the vial intravenously over 15 minutes. Use aseptic technique when preparing Acetaminophen (Zacoldine) Injection for intravenous infusion. Do not add other medications to the Acetaminophen (Zacoldine) Injection vial or infusion device.

For doses less than 1,000 mg, the appropriate dose must be withdrawn from the container and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed Acetaminophen (Zacoldine) Injection container and place the measured dose in a separate empty, sterile container (e.g., glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL container of Acetaminophen (Zacoldine) Injection is not intended for use in patients weighing less than 50 kg. Acetaminophen (Zacoldine) Injection is supplied in a single-dose container and the unused portion must be discarded.

Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump.

Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the Acetaminophen (Zacoldine) Injection infusion is the primary infusion.

Once the container seal has been penetrated, or the contents transferred to another container, administer the dose of Acetaminophen (Zacoldine) Injection within 6 hours.

Do not add other medications to the Acetaminophen (Zacoldine) Injection solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with Acetaminophen (Zacoldine) Injection, therefore do not administer simultaneously.

What other drugs will affect Acetaminophen (Zacoldine)?

Ask a doctor or pharmacist if it is safe for you to use Acetaminophen (Zacoldine) if you are also using any of the following drugs:

This list is not complete and there may be other drugs that can interact with Acetaminophen (Zacoldine). Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Acetaminophen (Zacoldine) interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Acetaminophen (Zacoldine), it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Acetaminophen (Zacoldine) is metabolized (eliminated by conversion to other chemicals) by the liver. Therefore drugs that increase the action of liver enzymes that metabolize Acetaminophen (Zacoldine) [for example, carbamazepine (Tegretol), isoniazid (INH, Nydrazid, Laniazid), rifampin (Rifamate, Rifadin, Rimactane)] reduce the levels of Acetaminophen (Zacoldine) and may decrease the action of Acetaminophen (Zacoldine). Doses of Acetaminophen (Zacoldine) greater than the recommended doses are toxic to the liver and may result in severe liver damage. The potential for Acetaminophen (Zacoldine) to harm the liver is increased when it is combined with alcohol or drugs that also harm the liver.

Cholestyramine (Questran) reduces the effect of Acetaminophen (Zacoldine) by decreasing its absorption into the body from the intestine. Therefore, Acetaminophen (Zacoldine) should be administered 3 to 4 hours after cholestyramine or one hour before cholestyramine.

Acetaminophen (Zacoldine) doses greater than 2275 mg per day may increase the blood thinning effect of warfarin (Coumadin) by an unknown mechanism. Therefore, prolonged administration or large doses of Acetaminophen (Zacoldine) should be avoided during warfarin therapy

Dosage of Chlorpheniramine maleate (Zacoldine) in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Tab Adult & childn >12 yr 1 tab tds-qds. Childn 6-12 yr ½ tab tds-qds. Syr Adult 5 mL tds-qds. Childn 6-12 yr 2.5 mL tds-qds, 2-5 yr 1.25 mL tds-qds.

What other drugs will affect Chlorpheniramine maleate (Zacoldine)?

Taking Chlorpheniramine maleate (Zacoldine) with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking Chlorpheniramine maleate (Zacoldine) with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Chlorpheniramine maleate (Zacoldine) interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Chlorpheniramine maleate (Zacoldine), it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), antispasmodics (e.g., atropine, belladonna alkaloids), drugs for Parkinson's disease (e.g., anticholinergics such as benztropine, trihexyphenidyl), scopolamine, tricyclic antidepressants (e.g., amitriptyline).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

Chlorpheniramine maleate (Zacoldine) is very similar to dexchlorpheniramine. Do not use medications containing dexchlorpheniramine while using Chlorpheniramine maleate (Zacoldine).

This medication may interfere with certain laboratory tests (including allergy skin testing), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Dosage of Phenylephrine (Zacoldine) in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Usual Adult Dose for Hypotension:

IM or subcutaneous: 2 to 5 mg every 1 to 2 hours as needed.

IV bolus: 0.2 mg/dose (range: 0.1 to 0.5 mg/dose) every 10 to 15 minutes as needed (initial dose should not exceed 0.5 mg)

IV infusion: 100 to 180 mcg/min initially. The usual maintenance dose is 40 to 60 mcg/min.

Alternatively, 0.5 mcg/kg/minute; titrate to desired response. Dosing ranges between 0.4 to 9.1 mcg/kg/minute have been reported.

Usual Adult Dose for Shock:

IM or subcutaneous: 2 to 5 mg every 1 to 2 hours as needed.

IV bolus: 0.2 mg/dose (range: 0.1 to 0.5 mg/dose) every 10 to 15 minutes as needed (initial dose should not exceed 0.5 mg)

IV infusion: 100 to 180 mcg/min initially. The usual maintenance dose is 40 to 60 mcg/min.

Alternatively, 0.5 mcg/kg/minute; titrate to desired response. Dosing ranges between 0.4 to 9.1 mcg/kg/minute have been reported.

Usual Adult Dose for Supraventricular Tachycardia:

0.25 to 0.5 mg IV over 30 seconds.

Usual Adult Dose for Nasal Congestion:

Tablets or oral liquid: 10 to 20 mg orally every 4 hours as needed.

Phenylephrine (Zacoldine) 7.5 mg/5 mL oral liquid:

15 mg orally every 6 hours not to exceed 60 mg daily.

Phenylephrine (Zacoldine) 10 mg oral tablet:

10 mg orally every 4 to 6 hours not to exceed 4 doses daily.

Phenylephrine (Zacoldine) 10 mg oral disintegrating strip:

10 mg orally every 4 hours not to exceed 6 doses daily.

Phenylephrine (Zacoldine) 10 mg/5 mL oral suspension, extended release:

10 to 20 mg orally every 12 hours.

Phenylephrine (Zacoldine) tannate 10 mg oral tablet, chewable, extended release:

10 to 20 mg orally every 12 hours.

Phenylephrine (Zacoldine) tannate 7.5 mg/5 mL oral suspension, extended release

7.5 to 15 mg orally every 12 hours.

Usual Pediatric Dose for Hypotension:

IM or subcutaneous: 0.1 mg/kg every 1 to 2 hours as needed. Maximum dose: 5 mg.

IV bolus: 5 to 20 mcg/kg/dose every 10 to 15 minutes as needed.

IV: 0.1 to 0.5 mcg/kg/min titrated to effect.

Usual Pediatric Dose for Shock:

IM or subcutaneous: 0.1 mg/kg every 1 to 2 hours as needed. Maximum dose: 5 mg.

IV bolus: 5 to 20 mcg/kg/dose every 10 to 15 minutes as needed.

IV: 0.1 to 0.5 mcg/kg/min titrated to effect.

Usual Pediatric Dose for Supraventricular Tachycardia:

5 to 10 mcg/kg IV over 30 seconds.

Usual Pediatric Dose for Nasal Congestion:

Phenylephrine (Zacoldine) 1.25 mg/0.8 mL oral liquid:

2 years to 5 years: 1.6 mL orally every 4 hours not to exceed 6 doses daily.

Chewable tablets or oral liquid:

6 years to 11 years: 10 mg orally every 4 hours as needed.

12 years or older: 10 to 20 mg orally every 4 hours as needed.

Phenylephrine (Zacoldine) 7.5 mg/5 mL oral liquid:

2 years to 5 years: 3.75 mg orally every 6 hours not to exceed 15 mg daily.

6 years to 11 years: 7.5 mg orally every 6 hours not to exceed 30 mg daily.

12 years or older: 15 mg orally every 6 hours not to exceed 60 mg daily.

Phenylephrine (Zacoldine) 10 mg oral tablet:

12 years or older: 10 mg orally every 4 to 6 hours not to exceed 4 doses daily.

Phenylephrine (Zacoldine) 10 mg oral tablet, disintegrating:

2 years to 5 years: 5 mg orally every 4 hours as needed.

6 years to 11 years: 10 mg orally every 4 hours as needed.

12 years or older: 10 to 20 mg orally every 4 hours as needed.

Phenylephrine (Zacoldine) 10 mg/5 mL oral suspension, extended release:

12 years or older: 10 to 20 mg orally every 12 hours.

6 years to 11 years: 5 to 10 mg orally every 12 hours.

Phenylephrine (Zacoldine) 10 mg oral disintegrating strip:

12 years or older: 10 mg orally every 4 hours not to exceed 6 doses daily.

Phenylephrine (Zacoldine) tannate 10 mg oral tablet, chewable, extended release:

6 years to 11 years: 5 to 10 mg orally every 12 hours.

12 years or older: 10 to 20 mg orally every 12 hours.

Phenylephrine (Zacoldine) tannate 7.5 mg/5 mL oral suspension, extended release

2 years to 5 years: 1.25 to 2.5 mL orally every 12 hours.

6 years to 11 years: 2.5 to 5 mL orally every 12 hours.

12 years or older: 5 to 10 mL orally every 12 hours.

Phenylephrine (Zacoldine) 1.25 mg oral disintegrating strip:

2 years to 3 years: 2.5 mg orally every 4 hours, not to exceed 15 mg in 24 hours.

Phenylephrine (Zacoldine) 2.5 mg oral disintegrating strip:

2 years to 5 years: 2.5 mg orally every 4 hours, not to exceed 15 mg in 24 hours.

6 years to 11 years: 5 mg orally every 4 hours, not to exceed 30 mg in 24 hours.

Phenylephrine (Zacoldine) 1.25 mg oral tablet, chewable:

12 years or older: 5 mg orally every 4 hours not to exceed 6 doses daily.

Phenylephrine (Zacoldine) 2.5 mg/5 mL oral liquid:

4 years to 5 years: 5 mL orally every 4 hours, not to exceed 6 doses in 24 hours.

6 years to 11 years: 10 mL orally every 4 hours, not to exceed 6 doses in 24 hours.

What other drugs will affect Phenylephrine (Zacoldine)?

Ask a doctor or pharmacist if it is safe for you to use Phenylephrine (Zacoldine) rectal if you are also using any of the following drugs:

This list is not complete and other drugs may interact with Phenylephrine (Zacoldine) rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Phenylephrine (Zacoldine) interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Phenylephrine (Zacoldine), it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.

Phenylephrine (Zacoldine): May increase the serum concentration of Phenylephrine (Zacoldine) (Systemic). Monitor therapy

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Benzylpenicilloyl Polylysine: Alpha1-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Consider therapy modification

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Chloroprocaine: May enhance the hypertensive effect of Phenylephrine (Zacoldine) (Systemic). Monitor therapy

CloZAPine: May diminish the therapeutic effect of Phenylephrine (Zacoldine) (Systemic). Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

FentaNYL: Alpha1-Agonists may decrease the serum concentration of FentaNYL. Specifically, fentanyl nasal spray serum concentrations may decrease and onset of effect may be delayed. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Hyaluronidase: May enhance the vasoconstricting effect of Phenylephrine (Zacoldine) (Systemic). Management: Avoid the use of hyaluronidase to enhance dispersion or absorption of Phenylephrine (Zacoldine). Use of hyaluronidase for other purposes in patients receiving Phenylephrine (Zacoldine) may be considered as clinically indicated. Avoid combination

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Avoid combination

Ioflupane I 123: Phenylephrine (Zacoldine) (Systemic) may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Exceptions: Linezolid. Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Propacetamol: May increase the serum concentration of Phenylephrine (Zacoldine) (Systemic). Management: Monitor patients closely for increased side effects of Phenylephrine (Zacoldine) if propacetamol is used concomitantly. Patients with underlying blood pressure issues or arrhythmias may need closer monitoring and may warrant consideration of alternative therapies. Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Tricyclic Antidepressants: May enhance the therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Monitor therapy



References

  1. DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. FDA/SPL Indexing Data. "362O9ITL9D: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).

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