Label: COUGH MUCUS RELIEF DM- dextromethorphan hbr and guaifenesin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70692-101-24, 70692-101-41 - Packager: Strive Pharmaceuticals Inc.
- 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.
Drug Label Information
Updated October 13, 2020
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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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 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COUGH MUCUS RELIEF DM
dextromethorphan hbr and guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) MALTODEXTRIN (UNII: 7CVR7L4A2D) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Product Characteristics Color white Score 2 pieces Shape OVAL Size 16mm Flavor Imprint Code S55 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-101-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2018 2 NDC:70692-101-41 4 in 1 PACKAGE; Type 0: Not a Combination Product 12/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/15/2018 Labeler - Strive Pharmaceuticals Inc. (080028013)
