MUCINEX CHILDRENS  COUGH 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 Mini-Melts™ Orange Crème

Drug Facts

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

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 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)

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 headache that lasts. These could be signs of a serious condition.

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
  • dose as follows or as directed by a doctor
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

  • each packet contains: magnesium 6 mg and 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

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

Made in Germany

PRINCIPAL DISPLAY PANEL - 12 Granule Packet Carton

Pediatrician Recommended*
NDC 63824-942-31

Mucinex®
Children's
COUGH

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

✓ Controls Cough
✓ Relieves Chest Congestion
✓ Breaks up Mucus

Ages
4+
years

Orange Creme
Flavor

12 GRANULE PACKETS

PRINCIPAL DISPLAY PANEL - 12 Granule Packet Carton
MUCINEX CHILDRENS   COUGH MINI-MELTS ORANGE CREME
dextromethorphan hydrobromide and guaifenesin granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-942
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:63824-942-3112 in 1 CARTON03/31/201902/25/2024
11 in 1 PACKET; Type 0: Not a Combination Product
2NDC:63824-942-1818 in 1 CARTON03/31/201902/25/2024
2NDC:63824-942-022 in 1 CARTON
21 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/31/201902/25/2024
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2021
Document Id: 45ab0502-ae94-434f-a8ef-cbcd47732f6b
Set id: f572a46a-4852-4b1f-9d4e-e08e432b9ce2
Version: 2
Effective Time: 20211222
 
RB Health (US) LLC