Label: TUSSIN DM COUGH AND CHEST CONGESTION ADULT- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 49580-0385-2, 49580-0385-4, 49580-0385-8
- Packager: P & L Development, LLC
- 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 January 28, 2021
If you are a consumer or patient please visit this version.
- 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-hour period
- measure only with the 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
Compare to the active ingredients in Robitussin® Peak Cold Cough + Chest Congestion DM*
tussin cough + chest congestion DM
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
- chest congestion
for ages 12 years +
Dosing Cup Included
FL OZ (mL)
*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 PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
11865 S. Alameda St
Lynwood, CA 90262
- Package Label
INGREDIENTS AND APPEARANCE
TUSSIN DM COUGH AND CHEST CONGESTION ADULT
dextromethorphan hbr, guaifenesin liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0385 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) FD&C RED NO. 40 (UNII: WZB9127XOA) DEXTROSE (UNII: IY9XDZ35W2) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0385-4 1 in 1 BOX 03/31/2015 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:49580-0385-8 1 in 1 BOX 03/31/2015 2 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:49580-0385-2 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 03/31/2015 Labeler - P & L Development, LLC (101896231)