DIABETIC SILTUSSIN DAS-NA - guaifenesin liquid 
Silarx Pharmaceuticals, Inc

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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Diabetic Siltussin DAS-Na

Active Ingredient: Guaifenesin 100 mg (in each 5 mL)

Purpose: Expectorant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Warnings


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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
Adult and children 12 years and over
2 teaspoonfuls
Children under 12 years
DO NOT USE

Other information
store at room temperature 20°-25°C (68°-77°F)

Phenylketonurics: contains phenylalanine 3 mg per teaspoonful (5 mL)

Inactive Ingredients

Acesulfame-K, aspartame, benzoic acid, citric acid, hydroxypropyl methyl cellulose, methylparaben, propylene glycol, strawberry flavor, and water.

Questions

888-974-5279

* This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributor of Robitussin®

Manufactured by:

Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave,
Carmel, NY 10512
USA


Container Label

DIABETIC SILTUSSIN DAS-NA 
guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54838-138
Route of Administration ORAL DEA Schedule     
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
acesulfame potassium (UNII: 23OV73Q5G9)  
aspartame (UNII: Z0H242BBR1)  
benzoic acid (UNII: 8SKN0B0MIM)  
anhydrous citric acid (UNII: XF417D3PSL)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY (strawberry flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-138-40 118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/05/2005
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 6/2014
Document Id: b98adb86-afb9-4e95-a8a2-3a5bbb8afadb
Set id: ee784e64-1a40-4492-a772-abb510084120
Version: 12
Effective Time: 20140627
 
Silarx Pharmaceuticals, Inc