![TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]](https://medic.hrt.org//dailymed/images/4af67ba7-8892-442c-b9fb-80aba9140e05/tussin-dm-cough-and-chest-congestion-ric-1.jpg)
| NDC | 49580-0385-4, 49580-0385-8 |
| Set ID | 4af67ba7-8892-442c-b9fb-80aba9140e05 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | P & L Development, LLC |
| 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 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*
adult
tussin cough + chest congestion DM
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
cough suppressant
expectorant
relieves:
- Cough
- chest congestion
- Mucus
for ages 12 years +
alcohol free
non-drowsy
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.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
- Package Label
-
INGREDIENTS AND APPEARANCE
TUSSIN DM COUGH AND CHEST CONGESTION ADULT
dextromethorphan hbr, guaifenesin liquidProduct 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)
