Siltussin SA (Guaifenesin Liquid)

Siltussin SA by

Drug Labeling and Warnings

Siltussin SA by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SILTUSSIN SA- guaifenesin liquid 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

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.

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

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, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, strawberry flavor.

Questions

1-844-834-0530

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Siltussin SA

GENERIC: Guaifenesin

DOSAGE: LIQUID

ADMINSTRATION: ORAL

NDC: 70518-2824-0

NDC: 70518-2824-1

NDC: 70518-2824-2

FLAVOR: STRAWBERRY

PACKAGING: 118 mL in 1 BOTTLE, PLASTIC

PACKAGING: 10 in 1 BOX

PACKAGING: 20 mL in 1 CUP, UNIT DOSE TYPE 0

ACTIVE INGREDIENT(S):

  • GUAIFENESIN 100mg in 5mL

INACTIVE INGREDIENT(S):

  • ANHYDROUS CITRIC ACID
  • D&C YELLOW NO. 10
  • FD&C BLUE NO. 1
  • FD&C RED NO. 40
  • GLYCERIN
  • MENTHOL
  • PROPYLENE GLYCOL
  • WATER
  • SACCHARIN SODIUM
  • SODIUM BENZOATE
  • SORBITOL

Remedy_Label

MM2

MM3

SILTUSSIN SA 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70518-2824(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)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (strawberry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70518-2824-0118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/202005/09/2023
2NDC: 70518-2824-110 in 1 BOX11/09/202105/09/2023
2NDC: 70518-2824-220 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/13/202005/09/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2023
 

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