Label: COUGH AND CONGESTION DM- dextromethorphan and guaifenesin capsule, liquid filled
Contains inactivated NDC Code(s)
NDC Code(s): 76168-060-37
- Packager: Velocity Pharma
- 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 September 6, 2016
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- Active Ingredient
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 that occurs with too much phlegm(mucus)
- cough that lasts or is chronic such as occur with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. This could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- Other Information
- Inactive Ingredients
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
COUGH AND CONGESTION DM
dextromethorphan and guaifenesin capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-060 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) POVIDONE (UNII: FZ989GH94E) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C RED NO. 40 (UNII: WZB9127XOA) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED (Light) Score no score Shape OVAL Size 20mm Flavor Imprint Code 601 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76168-060-37 16 in 1 BOTTLE 11/08/2015 1 1 in 1 CARTON; 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 11/08/2015 Labeler - Velocity Pharma (962198409) Registrant - Velocity Pharma (962198409)