Label: MUCUS RELIEF DM- dextromethorphan hydrobromide and guaifenesin tablet, film coated
- NDC Code(s): 41250-533-11
- Packager: Meijer
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredients (in each immediate-release tablet)
Dextromethorphan HBr 20 mgClose
Guaifenesin 400 mg
temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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
cough accompanied by too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
take with a full glass of water
adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use
- Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- Inactive ingredients
D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acidClose
- Principal Display Panel
Immediate Release Cough
Mucus Reliefer DM
Guaifenesin • Dextromethorphan HBr
Expectorant • Cough Suppressant
Things and Loosens Mucus
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DIST. BY MEIJER
2929 WALKER AVE NW,
GRAND RAPIDS, MI 49544
- INGREDIENTS AND APPEARANCE
MUCUS RELIEF DM
dextromethorphan hbr and guiafenesin tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-533 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color YELLOW Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;533 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-533-11 1 in 1 CARTON 1 60 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/31/2005 Labeler - Meijer (006959555) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(41250-533)