Label: SILTUSSIN SA- guaifenesin liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 17856-0117-1, 17856-0117-2, 17856-0117-5 - Packager: Atlantic Biologicals Corps
- This is a repackaged label.
- Source NDC Code(s): 54838-117
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 30, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
- cough that occurs with too much phlegm (mucus)
-
Directions
- do not take more than 6 doses in any 24-hour period
- repeat dose every 4 hours
adults and children 12 years and over
2-4 teaspoonfuls (TSP)
children under 12 years DO 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 - do not take more than 6 doses in any 24-hour period
- Inactive ingredients
- Questions
- SILTUSSIN SA (GUAIFENESIN) LIQUID
-
INGREDIENTS AND APPEARANCE
SILTUSSIN SA
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0117(NDC:54838-117) 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 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 Shape Size Flavor STRAWBERRY (strawberry flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-0117-1 15 mL in 1 CUP; Type 0: Not a Combination Product 05/03/2016 10/16/2019 2 NDC:17856-0117-2 10 mL in 1 CUP; Type 0: Not a Combination Product 05/03/2016 10/16/2019 3 NDC:17856-0117-5 5 mL in 1 CUP; Type 0: Not a Combination Product 10/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/05/1998 Labeler - Atlantic Biologicals Corps (047437707) Registrant - Atlantic Biologicals Corps (047437707) Establishment Name Address ID/FEI Business Operations Atlantic Biologicals Corps 047437707 RELABEL(17856-0117) , REPACK(17856-0117)
