Tussin Dm
FDA Label NDC 76140-106

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Davagen Pharmaceutical, Llc for the product Tussin Dm (NDC 76140-106). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, do not use, otc - ask doctor, other, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Purpose

→ Uses

→ Do Not Use

→ Otc - Ask Doctor

→ Other

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Other Information

→ Inactive Ingredients

→ Directions

→ Principal Display Panel - 237 Ml Bottle Label

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