MUCINEX CHILDRENS COUGH AND CHEST CONGESTION MINI-MELTS ORANGE CREME- dextromethorphan hydrobromide and guaifenesin granule

Mucinex Childrens by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each packet)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves cough as may occur with a cold.

Warnings

Do not useif 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

• persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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
• do not give more than 6 doses in any 24-hour period
• dose as follows or as directed by a doctor

Age	Dose
adults and Children 12 years of age and over	2 to 4 packets every 4 hours
children 6 years to under 12 years of age	1 to 2 packets every 4 hours
children 4 years to under 6 years of age	1 packet every 4 hours
children under 4 years of age	do not use

Other information

• each packet contains: magnesium 6 mgand sodium 3 mg
• phenylketonurics: contains phenylalanine 2 mg per packet
• store at 20-25°C (68-77°F)

Inactive ingredients

aspartame, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate

Questions?

1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

Made in Germany

PRINCIPAL DISPLAY PANEL - 12 Packet Carton

Pediatrician Recommended*

NDC: 63824-943-12

Mucinex®
children's

COUGH AND
CHEST CONGESTION

Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant

• Controls Cough
• Relieves Chest Congestion
• Thins and Loosens Mucus

Ages
4 +years

Orange Crème
Flavor

12 GRANULE PACKETS

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS  COUGH AND CHEST CONGESTION MINI-MELTS ORANGE CREME
dextromethorphan hydrobromide and guaifenesin granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-943
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-943-12	12 in 1 CARTON	01/27/2022
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 63824-943-02	2 in 1 PACKAGE	01/27/2022
2		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	01/27/2022

Labeler - RB Health (US) LLC (081049410)