Label: CHILDRENS MUCINEX MINI-MELTS COUGH- dextromethorphan hydrobromide and guaifenesin granule
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated November 14, 2014
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
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.
- 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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 12 Packet Carton
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)