MUCINEX CHILDRENS  COUGH AND CHEST CONGESTION MINI-MELTS ORANGE CREME- dextromethorphan hydrobromide and guaifenesin granule 
RB Health (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mucinex® Children's
Cough & Chest Congestion Mini-Melts Orange Crème

Drug Facts

Active ingredients (in each packet)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant

Uses

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 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 if cough 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

AgeDose
adults and Children 12 years of age and over2 to 4 packets every 4 hours
children 6 years to under 12 years of age1 to 2 packets every 4 hours
children 4 years to under 6 years of age1 packet every 4 hours
children under 4 years of agedo not use

Other information

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.

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

PRINCIPAL DISPLAY PANEL - 12 Packet Carton
MUCINEX CHILDRENS   COUGH AND CHEST CONGESTION MINI-MELTS ORANGE CREME
dextromethorphan hydrobromide and guaifenesin granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-943
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-943-1212 in 1 CARTON01/27/2022
11 in 1 PACKET; Type 0: Not a Combination Product
2NDC:63824-943-022 in 1 PACKAGE01/27/2022
21 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/27/2022
Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022
Document Id: a3080d71-61a2-4814-a63e-3fe61121ab26
Set id: 66543190-1d3d-4259-ae73-d366ecbf9e52
Version: 1
Effective Time: 20220131
 
RB Health (US) LLC