Mucinex Children's Mighty Chews Cough Nighttime

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Doxylamine (3.125 mg) Acetaminophen (162.5 mg)

Inactive Ingredients

Malic Acid Corn Syrup Fd&c Blue No. 1 Sodium Chloride Anhydrous Trisodium Citrate Sucralose Sodium Polymetaphosphate Sucrose Anhydrous Citric Acid Ethylcellulose Fd&c Red No. 40 Maltodextrin Pectin Potassium Sodium Tartrate Water Glycerin

Identifiers & Packaging

Pill Appearance

Imprint: M Shape: round Color: purple Size: 23 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-01

Medication Information

Warnings and Precautions

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.

Dosage and Administration

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

Description

Acetaminophen 162.5 mg Dextromethorphan HBr 5 mg Doxylamine succinate 3.125 mg

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

Section 50565-1

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.

Section 51727-6

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)

Section 51945-4

NDC 72854-085-16

Children's

Mucinex®

Cough Suppressant

Antihistamine

Acetaminophen 162.5 mg

Dextromethorphan HBr 5 mg

Doxylamine succinate 3.125 m

Age 6+

Mixed Berry Flavor

Section 53413-1

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

Section 55105-1

Acetaminophen 162.5 mg................................................Pain reliever/fever reducer

Dextromethorphan HBr 5 mg.......................... ...............Cough suppressant

Doxylamine succinate 3.125 mg.................................................Antihistamine

Section 55106-9

Acetaminophen 162.5 mg

Dextromethorphan HBr 5 mg

Doxylamine succinate 3.125 mg

Section 60561-8

Other information

■ each chewable tablet contains: potassium 5 mg and sodium 13 mg

■ Store in a cool dry place at 20-25°C (68-77°F)

Structured Label Content