NDC | 55319-385-08 |
Set ID | 691f5813-10bb-461c-b565-d6564dc9820d |
Category | HUMAN OTC DRUG LABEL |
Packager | Family Dollar (FAMILY WELLNESS) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- 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 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 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)