Mucinex Childrens Mighty Chews Night Time Cold and Flu

Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate · Tablet, Chewable · Oral

Over the counter Antihistamine Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist

Active ingredient

Acetaminophen 162.5 mg Dextromethorphan HBr 5 mg Doxylamine succinate 3.125 mg

Purpose

Acetaminophen 162.5 mg................................................Pain reliever/fever reducer Dextromethorphan HBr 5 mg.......................... ...............Cough suppressant Doxylamine succinate 3.125 mg.................................................Antihistamine

Uses

Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ sore throat ■ headache ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ runny nose ■ sneezing ■ temporarily reduces fever ■ controls cough to help the user get to sleep

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: ■ adult takes more than 6 doses (24 chewable tablets) in 24 hours, which is the maximum daily amount ■ child takes more than 5 doses (10 chewable tablets) in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day 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 ■ to make a child sleepy ■ 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 the user is 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 ■ has liver disease ■ has a sodium-restricted diet ■ has glaucoma ■ has a breathing problem such as emphysema or chronic bronchitis ■ has difficulty in urination due to enlargement of the prostate gland ■ is a child with pain of arthritis 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 (see Overdose warning) ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) ■ 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.

Keep out of reach of children

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Directions ■ do not take more than directed (see Overdose warning) ■ chew thoroughly before swallowing ■ dose every 4 hours or as directed by a doctor adults and children 12 years of age and over 4 chewable tablets every 4 hours, not to exceed 6 doses (24 chewable tablets) in any 24-hour period children 6 to under 12 years of age 2 chewable tablets every 4 hours, not to exceed 5 doses (10 chewable tablets) in any 24-hour period children under 6 years of age do not use

Inactive ingredients

Inactive ingredients anhydrous citric acid, corn syrup, ethylcellulose, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, malic acid, maltodextrin, pectin, potassium sodium tartrate, purified water, sodium chloride, sodium polymetaphosphate, sucralose, sucrose, trisodium citrate (anhydrous)

Questions?

Questions? 1-866-MUCINEX (1-866-682-4639)

Label text from the FDA structured product label by Reckitt Benckiser LLC (revised May 13, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Mucinex Childrens Mighty Chews Night Time Cold and Flu NDC products (1)

NDCStrength & formLabelerType
72854-085Dextromethorphan Hydrobromide 5 mg/1; Doxylamine Succinate 3.125 mg/1; Acetaminophen 162.5 mg/1
Tablet, Chewable
Reckitt Benckiser LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is Mucinex Childrens Mighty Chews Night Time Cold and Flu used for?

Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ sore throat ■ headache ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ runny nose ■ sneezing ■ temporarily reduces fever ■ controls cough to help the user get to sleep

Who makes Mucinex Childrens Mighty Chews Night Time Cold and Flu?

Mucinex Childrens Mighty Chews Night Time Cold and Flu is listed by 1 labeler in the FDA NDC directory, including Reckitt Benckiser LLC.