Label: ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 21130-385-04, 21130-385-08
- Packager: Safeway, 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 January 4, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
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.
- do not take more than 6 doses in any 24-hours period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = milliliter
- this adult product is not intended for use in children under 12 years of age
- adults and children 12 years and over: 10 mL every 4 hours
- children under 12 years: do not use
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
AGES 12 & OVER
Non-Drowsy Adult Cough + Chest Congestion Relief DM
Dextromethorphan HBr 20 mg-Cough Suppressant
Guaifenesin 200 mg-Expectorant
Compare to Robitussin® Peek Cold Cough + Chest Congestion DM active ingredients*
- Relief of: Cough, chest congestion
- For ages 12 & over
- Alcohol free
- Dosing cup included
*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Cough & Chest Congestion DM.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
BETTER LIVING BRANDS LLC
P.O BOX 99, PLEASANTON, CA 94566-0009
- Package Label
INGREDIENTS AND APPEARANCE
ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY
dextromethorphan hbr, guaifenesin liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-385 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 in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) MENTHOL (UNII: L7T10EIP3A) GLUCOSE OXIDASE (UNII: 0T8392U5N1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-385-04 1 in 1 BOX 06/30/2014 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:21130-385-08 1 in 1 BOX 06/30/2014 2 237 mL in 1 BOTTLE, PLASTIC; 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 06/30/2014 Labeler - Safeway, Inc. (009137209)