SELECTHEALTH TUSSIN DM- guaifenesin liquid 
Axcentria Pharmaceuticals, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by 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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Tussin
DM

Drug Facts

Active ingredient
(in each 5 mL tsp)
Purposes
Dextromethorphan HBr, USP 10 mgCough suppressant
Guaifenesin, USP 100 mgExpectorant

Uses

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

Other information

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

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:

NON-DROWSY
AGES 12+

NET 8 FL OZ
(240 ML)

NDC 49743-3001-1

Principal Display Panel
SELECTHEALTH TUSSIN DM 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49743-3001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Menthol (UNII: L7T10EIP3A)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Glycerin (UNII: PDC6A3C0OX)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49743-3001-1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2011
Labeler - Axcentria Pharmaceuticals, LLC. (961871501)
Establishment
NameAddressID/FEIBusiness Operations
Axcentria Pharmaceuticals, LLC.961871501MANUFACTURE

Revised: 8/2011
Document Id: 7da063a7-3c4f-4626-b1c9-70bfd6488314
Set id: b6398868-d4cd-4d1e-9984-41cd492853ed
Version: 1
Effective Time: 20110826
 
Axcentria Pharmaceuticals, LLC.