Label: MUCUS RELIEF DM IMMEDIATE RELEASE- dextromethorphan hbr and guaifenesin tablet
- NDC Code(s): 69168-543-26, 69168-543-60
- Packager: Allegiant Health
- 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 December 10, 2018
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- Active ingredient (in each tablet)
Dextromethorphan HBr 20mgClose
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways and make coughs more productive
- temporarily relieves:
- cough due to minor sore 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 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 am 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 accompanied by too much phlegm (mucus)
Stop use and ask a doctor if
cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
Children under 12 years of age: do not useClose
- Other information
- store at 25ºC (77ºF) excursions between 15º-30ºC (59º-86ºF)
- keep in a dry place and do not expose to heat
- do not use if imprinted safety seal under cap is broken or missing
- You may report side effects to 1-888-952-0500.
- Inactive ingredients
croscarmellose sodium, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acidClose
- Principal Display Panel
Mucus Relief DM
- INGREDIENTS AND APPEARANCE
MUCUS RELIEF DM IMMEDIATE RELEASE
dextromethorphan hbr and guaifenesin tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-543 Route of Administration ORAL 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code AZ345 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-543-26 1 in 1 CARTON 12/23/2014 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-543-60 1 in 1 CARTON 12/23/2014 2 60 in 1 BOTTLE; 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 12/23/2014 Labeler - Allegiant Health (079501930)