MU

OTC products · Product label record

MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu drug information

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE
Reckitt Benckiser LLC · ORAL

Product NDC: 72854-168

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Generic nameACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE
Labeler / manufacturerReckitt Benckiser LLC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC72854-168
Label effective date2026-09-09

Official product label reference

MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu — Reckitt Benckiser LLC

This page contains 10 source sections for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE, oral route. Label set 3856c1e4-814f-85c4-e063-6394a90ab8a8, version 4.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Day: ■ temporarily relieves these common cold and flu symptoms: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep ■ minor aches and pains ■ sore throat ■ headache ■ temporarily reduces fever Night: ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ minor aches and pains ■ sore throat ■ headache ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep

Purpose

Purpose Day: Acetaminophen 325 mg...Pain reliever/fever reducer Dextromethorphan HBr 10 mg.......Cough suppressant Purpose Night: Acetaminophen 325 mg...Pain reliever/fever reducer Dextromethorphan HBr 10 mg.......Cough suppressant Doxylamine succinate 6.25 mg............. Antihistamine
Dosage and administration — label text
Day: Directions ■ do not take more than directed (see Overdose warning) ■ do not take more than 12 capsules in any 24-hour period ■ adults and children 12 years of age and over: take 2 capsules every 4 hours ■ children under 12 years of age: do not use Night: Directions ■ do not take more than directed (see Overdose warning) ■ do not take more than 12 capsules in any 24-hour period ■ adults and children 12 years of age and over: take 2 capsules every 4 hours ■ children under 12 years of age: do not use
Warnings
Day: Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 12 capsules in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have ■ liver disease ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Night: Severe liver damage may occur if you take: ■ more than 12 capsules in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have ■ liver disease ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not use more than directed ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery
Unclassified section
Active ingredient
Day: Acetaminophen 325 mg Dextromethorphan HBr 10 mg Night: Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg
Other safety information
Other information ■ store at 20-25°C (68-77°F) ■ avoid excessive heat
Child safety
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Inactive ingredient
Day : FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin (sunflower), light mineral oil, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, 1,4-sorbitan, sorbitol, titanium dioxide Night: D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin (sunflower), light mineral oil, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, 1,4-sorbitan, sorbitol, titanium dioxide
Questions
Questions? 1-866-MUCINEX (1-866-682-4639)

Official sources and product identifiers

RxNorm identifiers: 1426334, 1867684, 2663936

Package NDC codes

72854-168-10, 72854-168-24, 72854-168-48, 72854-171-08

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.