CHILDRENS MUCINEX MINI-MELTS COUGH- dextromethorphan hydrobromide and guaifenesin granule

Childrens Mucinex by

Drug Labeling and Warnings

Childrens Mucinex by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each packet)	Purpose
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 due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep

Warnings

Do not use if 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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a healthcare 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 take more than 6 doses in any 24-hour period

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

Other information

• each packet contains: magnesium 6 mg and sodium 3 mg
• phenylketonurics: contains phenylalanine 2 mg per packet
• store between 20-25°C (68-77°F)
• tamper evident: do not use if carton is open or if packets are torn or open

Inactive ingredients

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

Questions?

1-866-MUCINEX(682-4639)
You may also report side effects to this phone number.

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Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 12 Packet Carton

NDC: 63824-256-12

Children's
Mucinex®

Cough
Expectorant
Cough Suppressant

Guaifenesin 100 mg / Dextromethorphan HBr 5 mg

mini-melts™

✓ Cough
✓ Chest Congestion
✓ Breaks up Mucus

Orange Creme
Flavor

12 GRANULE PACKETS

INGREDIENTS AND APPEARANCE

CHILDRENS MUCINEX   MINI-MELTS COUGH
dextromethorphan hydrobromide and guaifenesin granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-256
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)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
povidones (UNII: FZ989GH94E)
sodium bicarbonate (UNII: 8MDF5V39QO)
carboxymethylcellulose sodium (UNII: K679OBS311)
sorbitol (UNII: 506T60A25R)
stearic acid (UNII: 4ELV7Z65AP)
talc (UNII: 7SEV7J4R1U)
triethyl citrate (UNII: 8Z96QXD6UM)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	ORANGE (Orange Crème)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-256-12	12 in 1 CARTON
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 Final	part341	03/24/2009

Labeler - Reckitt Benckiser (094405024)