SILTUSSIN SA- guaifenesin liquid 
Atlantic Biologicals Corps

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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Siltussin SA (Guaifenesin Liquid)

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

Purpose: Expectorant

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

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

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. Stop use and ask a doctor

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

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

Directions


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

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

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.

Questions

888-974-5279

SILTUSSIN SA (GUAIFENESIN) LIQUID

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SILTUSSIN SA 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0117(NDC:54838-117)
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
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 (UNII: SB8ZUX40TY)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium citrate (UNII: 1Q73Q2JULR)  
sorbitol (UNII: 506T60A25R)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (strawberry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0117-115 mL in 1 CUP; Type 0: Not a Combination Product05/03/201610/16/2019
2NDC:17856-0117-210 mL in 1 CUP; Type 0: Not a Combination Product05/03/201610/16/2019
3NDC:17856-0117-55 mL in 1 CUP; Type 0: Not a Combination Product10/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/05/1998
Labeler - Atlantic Biologicals Corps (047437707)
Registrant - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL(17856-0117) , REPACK(17856-0117)

Revised: 7/2020
Document Id: ac983a67-c78b-4c21-9dae-357f460cd68b
Set id: 7b1415d8-5af2-4749-9421-22f01842e1f6
Version: 4
Effective Time: 20200730
 
Atlantic Biologicals Corps