Selecthealth Tussin Dm
FDA Label NDC 49743-3001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Axcentria Pharmaceuticals, Llc. for the product Selecthealth Tussin Dm (NDC 49743-3001). 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 other, otc - purpose, uses, otc - do not use, ask a doctor before use if you have, 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

→ Other

→ Otc - Purpose

→ Uses

→ Otc - Do Not Use

→ Ask A Doctor Before Use If You Have

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 240 Ml Bottle Carton

Other

Drug Facts

Distributed by:
Axcentria Pharmaceuticals, LLC.
306 Keystone Drive
Telford, PA 18969 USA

Otc - Purpose

Active ingredient (in each 5 mL tsp)	Purposes
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.

Otc - Do Not Use

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 you prescription 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

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.

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
adults and children 12 years of age and over
2 teaspoons every 4 hours
children under 12 years do not use

Other Information

each teaspoon contains: sodium 7 mg
store 20 to 25°C (68 to 77°F)
dosage cup provided

Inactive Ingredients

anhydrous citric acid, FD&C red no.40, glycerin, high fructose corn syrup, menthol, natural flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose