Label: TUSSIN DM- dextromethorphan hydrobromide and guaifenesin liquid
- NDC Code(s): 76140-106-08
- Packager: davAgen Pharmaceutical, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Active ingredients (in each 5 mL tsp): Purpose Dextromethorphan HBr, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold; helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.Close
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) or a 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Other information
Each tsp contains: sodium 6.5 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate.
Dosage cup provided.Close
- Inactive ingredients
citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucraloseClose
do not take more than 6 doses in any 24-hour period
- this adult product is not intended for use in children under 12 years of age
- mL = milliliter; tsp = teaspoonful
age dose adults and children 12 years and over 10 mL (2 tsp) every 4 hours children under 12 years do not use
- SPL UNCLASSIFIED SECTION
Somerset, NJ 08873
- PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
Adults & Children Ages 12 & Older
Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin
For Relief of:
- Chest Congestion & Mucus
8 FL OZ (237 mL)
- INGREDIENTS AND APPEARANCE
dextromethorphan hydrobromide and guaifenesin liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76140-106 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg in 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength Sodium Benzoate (UNII: OJ245FE5EU) Citric Acid Monohydrate (UNII: 2968PHW8QP) Sorbitol (UNII: 506T60A25R) Saccharin Sodium (UNII: SB8ZUX40TY) Sucralose (UNII: 96K6UQ3ZD4) FD&C Red No. 40 (UNII: WZB9127XOA) Propylene Glycol (UNII: 6DC9Q167V3) Glycerin (UNII: PDC6A3C0OX) Sodium Citrate (UNII: 1Q73Q2JULR) Menthol (UNII: L7T10EIP3A) Water (UNII: 059QF0KO0R) Product Characteristics Color RED Score Shape Size Flavor TROPICAL FRUIT PUNCH, ORANGE, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76140-106-08 1 in 1 CARTON 1 236 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/10/2013 Labeler - davAgen Pharmaceutical, LLC (967545935) Establishment Name Address ID/FEI Business Operations davAgen Pharmaceutical, LLC 967545935 MANUFACTURE(76140-106) , PACK(76140-106) , LABEL(76140-106) , ANALYSIS(76140-106)