Label: SILACE- docusate sodium liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-0116-2 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 54838-116
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 October 26, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warning
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
- take as indicated by doctor
- this product must be given in a 6 to 8 oz. glass of milk or fruit juice or infant's formula to prevent throat irritation. Dose may be taken as a single daily dose or in divided doses
- dosage should be adjusted to individual response
- higher doses are recommended for initial therapy
- the effect on stools is usually apparent 1 to 3 days after the first dose
Adults and children over 12 years 50 to 200 mg (1 to 4 teaspoonful) Children 6 to under 12 years 50 to 100 mg (1 to 2 teaspoonful) Children 3 to under 6 years 25 to 50 mg(1/2 to 1 teaspoonful) Children under 3 years of age Ask a doctor - Other information
- Inactive ingredients
- QUESTIONS
- 17856-0116-02
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INGREDIENTS AND APPEARANCE
SILACE
docusate sodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0116(NDC:54838-116) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Docusate sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate sodium 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) D&C red no. 33 (UNII: 9DBA0SBB0L) methylparaben (UNII: A2I8C7HI9T) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) sodium citrate (UNII: 1Q73Q2JULR) water (UNII: 059QF0KO0R) Poloxamer 407 (UNII: TUF2IVW3M2) Product Characteristics Color Score Shape Size Flavor LEMON (Lemon Vanilla Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-0116-2 25 mL in 1 CUP; Type 0: Not a Combination Product 10/07/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/05/1990 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 repack(17856-0116) , relabel(17856-0116)