MUCINEX CHILDRENS MIGHTY CHEWS NIGHT TIME COLD AND FLU- acetaminophen, dextromethorphan hbr and doxylamine succinate tablet, chewable

Mucinex Childrens Mighty Chews Night Time Cold and Flu by

Drug Labeling and Warnings

Mucinex Childrens Mighty Chews Night Time Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

■ 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.

DOSAGE & 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

OTHER SAFETY INFORMATION

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)

INACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS MIGHTY CHEWS NIGHT TIME COLD AND FLU 
acetaminophen, dextromethorphan hbr and doxylamine succinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-085
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	3.125 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	162.5 mg

Inactive Ingredients
Ingredient Name	Strength
MALIC ACID (UNII: 817L1N4CKP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
SUCROSE (UNII: C151H8M554)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PECTIN (UNII: 89NA02M4RX)
POTASSIUM SODIUM TARTRATE (UNII: QH257BPV3J)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	purple	Score	no score
Shape	ROUND	Size	23mm
Flavor	BERRY (Mixed Berry)	Imprint Code	M
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-085-16	16 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	06/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2025

Labeler - RB Health (US) LLC (081049410)