MUCINEX CHILDRENS MINI MELTS COLD AND FLU- acetaminophen and guaifenesin granule

Drug Labeling and Warnings

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each packet)
Acetaminophen 162.5 mg
Guaifenesin 100 mg

Active ingredients (in each packet)	Purposes
Acetaminophen 162.5 mg	Fever Reducer/Pain Reliever
Guaifenesin 100 mg	Expectorant

Uses

Temporarily relieves minor aches and pains due to:

■ the common cold ■ flu ■ headache ■ sore throat
■ temporarily reduces fever
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways
of bothersome mucus and make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if
■ adult takes more than 6 doses (24 packets) in 24 hours, which is the maximum daily amount
■ child takes more than 5 doses (10 packets) 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 ■ blister ■ 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.

Ask a doctor before use if you have

Ask a doctor before use if the user has
■ liver disease ■ persistent or chronic cough that lasts such as occurs with smoking, asthma,
chronic bronchitis, or emphysema ■ cough accompanied by too much phlegm (mucus)

Ask a doctor or pharmacist before use if the user is 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 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.

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• empty entire contents of packet onto tongue and swallow
• for best taste, do not chew granules

Age	Dose
adults and Children 12 years of age and over	2 to 4 packets every 4 hours, not to exceed 6 doses (24 packets) in 24 hours
children 6 years to under 12 years of age	2 packets every 4 hours, not to exceed 5 doses (10 packets) in 24 hours
children under 6 years of age	do not use

Other information

• each packet contains: magnesium 5 mg and sodium 3 mg
• store at 20-25°C (68-77°F)

Inactive ingredients

amino methacrylate copolymer,
carbomer homopolymer type A,
carboxymethylcellulose sodium,
hypromellose, magnesium
stearate, microcrystalline
cellulose, povidone, colloidal
silicon dioxide, simethicone,
sodium bicarbonate, sorbitol,
sodium lauryl sulphate, sucralose,
stearic acid, strawberry flavor,
talc, triethyl citrate, vanilla flavor

Questions?

1-866-682-4639

You may also report side effects to this phone number.

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Dist. By: RB Health (US)
Parsippany, NJ 07054-0224

Made in Germany

PRINCIPAL DISPLAY PANEL - 12 Packet Carton

Pediatrician Recommended*

NDC: 72854-090

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS  MINI MELTS COLD AND FLU
acetaminophen and guaifenesin granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-090
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	162.5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg

Inactive Ingredients
Ingredient Name	Strength
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	STRAWBERRY (STRAWBERRY VANILLA)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-090-12	12 in 1 CARTON	04/05/2026
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/05/2026

Labeler - RB Health (US) LLC (081049410)