FDA Label for Tussin Dm
View Indications, Usage & Precautions
Tussin Dm Product Label
The following document was submitted to the FDA by the labeler of this product Davagen Pharmaceutical, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
Active ingredients (in each 5 mL tsp): | Purpose |
---|---|
Dextromethorphan HBr, USP 10 mg | Cough suppressant |
Guaifenesin, USP 100 mg | Expectorant |
Uses
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.
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.
Otc - Ask Doctor
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
Other
Do not exceed recommended dose
Manufactured by:
davAgen
Pharmaceutical LLC
Somerset, NJ 08873
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
Inactive Ingredients
citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Directions
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 |
Principal Display Panel - 237 Ml Bottle Label
davAgen
pharmaceutical
NDC 76140-106-08
Adults & Children Ages 12 & Older
Tussin DM
Cough &
Chest Congestion
Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin
For Relief of:
- Cough
- Chest Congestion & Mucus
8 FL OZ (237 mL)
* Please review the disclaimer below.