SELECTHEALTH TUSSIN DM- guaifenesin liquid

SelectHealth Tussin DM by

Drug Labeling and Warnings

SelectHealth Tussin DM by is a Otc medication manufactured, distributed, or labeled by Axcentria Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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.

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 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

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.

If pregnant or breast-feeding, ask a health professional before use.

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

Questions?

Adverse drug event call (888) 933-3222

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 240 ML Bottle Carton

*COMPARE TO the active ingredient
in ROBITUSSIN PEAK COLD

Tussin
DM

HealthSelect®

Cough & Chest
Congestion DM

Dextromethorphan HBr, USP
Cough Suppressant

Antitusiv-Dextrometorfano HBr
Expectorant

Relieves:

• Cough
• Chest Congestion

NON-DROWSY
AGES 12+

NET 8 FL OZ
(240 ML)
NDC: 49743-3001-1

INGREDIENTS AND APPEARANCE

SELECTHEALTH TUSSIN DM 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49743-3001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Menthol (UNII: L7T10EIP3A)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)
Glycerin (UNII: PDC6A3C0OX)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49743-3001-1	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/01/2011

Labeler - Axcentria Pharmaceuticals, LLC. (961871501)

Establishment
Name	Address	ID/FEI	Business Operations
Axcentria Pharmaceuticals, LLC.		961871501	MANUFACTURE