Label: MAXIMUM STRENGTH CHEST CONGESTION AND COUGH- dextromethorphan hydrobromide and guaifenesin capsule, gelatin coated
- NDC Code(s): 69842-783-20
- Packager: CVS PHARMACY, 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 November 18, 2022
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- SPL UNCLASSIFIED SECTION
- 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 occurs 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. These could be signs of a serious condition.
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH CHEST CONGESTION AND COUGH
dextromethorphan hydrobromide and guaifenesin capsule, gelatin coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-783 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 FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red (Light red) Score no score Shape OVAL (Oblong) Size 20mm Flavor Imprint Code 905;242 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-783-20 2 in 1 CARTON 01/13/2021 1 10 in 1 BLISTER PACK; 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 01/13/2021 Labeler - CVS PHARMACY, INC. (062312574)