SILTUSSIN SA- 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.


Siltussin SA (Guaifenesin Liquid)

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

Purpose: Expectorant

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


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.


adults and children 12 years and over
2-4 teaspoonfuls (TSP)
children under 12 years DO NOT USE

Other information

Store at room temperature 20°-25°C (68°-77°F). Do not accept if imprinted tamper evident safety seal around cap is broken or missing.

Inactive ingredients

citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, strawberry flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, purified water.



Manufactured by:

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

Container Label 118mL

guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54838-117
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
anhydrous citric acid (UNII: XF417D3PSL)  
D&C yellow no. 10 (UNII: 35SW5USQ3G)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C red no. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
propylene glycol (UNII: 6DC9Q167V3)  
saccharin sodium dihydrate (UNII: SB8ZUX40TY)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium citrate (UNII: 1Q73Q2JULR)  
sorbitol (UNII: 506T60A25R)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY (strawberry flavor) Imprint Code
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-117-40 118 mL in 1 BOTTLE, PLASTIC
2 NDC:54838-117-70 237 mL in 1 BOTTLE, PLASTIC
3 NDC:54838-117-80 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/05/1998
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 6/2014
Document Id: 65e995d0-c415-4e7f-a6c5-6f567899f684
Set id: 42d3ce76-5a3d-4936-bc75-2f703dd3b423
Version: 15
Effective Time: 20140627
Silarx Pharmaceuticals, Inc