Label: SILACE- docusate sodium syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-6311-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 54838-107
- 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 June 14, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- take as directed by a doctor
- doses must be given in a 6-8 oz glass of milk or fruit juice, to prevent throat irritation
- dose may be taken as a single daily dose or in divided doses
- dosage should be adjusted to individual response
Adults and children 12 years of age and older
1 to 6 tablespoonfuls, or as directed by a doctor
Children 6 to under 12 years of age
1 to 2 1/2 tablespoonfuls, or as directed by a doctor
Children under 6 years
Ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SILACE
docusate sodium syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6311(NDC:54838-107) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Docusate sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate sodium 60 mg in 15 mL Inactive Ingredients Ingredient Name Strength alcohol (UNII: 3K9958V90M) citric acid (UNII: 2968PHW8QP) D&C red no. 33 (UNII: 9DBA0SBB0L) FD&C red no. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) methylparaben (UNII: A2I8C7HI9T) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sodium citrate (UNII: 1Q73Q2JULR) sucrose (UNII: C151H8M554) Product Characteristics Color Score Shape Size Flavor PEPPERMINT (peppermint Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6311-0 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/22/2011 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel, repack