Label: TUSSIN COUGH AND CHEST CONGESTION DM ADULT- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 55319-385-08
- Packager: Family Dollar (FAMILY WELLNESS)
- 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 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
- Purposes
- Uses
-
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
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
-
Directions
- do not take more than 6 doses in any 24-hour 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
COMPARE TO THE ACTIVE INGREDIENTS OF ROBITUSSIN® PEAK COLD COUGH + CHEST CONGESTION DM*
ADULT
Tussin Cough & Chest Congestion DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (EXPECTORANT)
Relieves
- Cough
- Mucus
DM
Alcohol-free
For Ages 12 and Over
Non-Drowsy
FL OZ (mL)
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.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
- Package Label
-
INGREDIENTS AND APPEARANCE
TUSSIN COUGH AND CHEST CONGESTION DM ADULT
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-385 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) 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:55319-385-08 1 in 1 BOX 02/28/2015 12/31/2025 1 237 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 02/28/2015 12/31/2025 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
