Label: COLACE- docusate sodium capsule
-
Contains inactivated NDC Code(s)
NDC Code(s): 70518-3319-0 - Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 67618-101
- Category: HUMAN OTC DRUG LABEL
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 January 5, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- ASK DOCTOR/PHARMACIST
- DO NOT USE
-
PREGNANCY OR BREAST FEEDING
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: Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over take 1-3 capsules daily children 2 to under 12 years of age take 1 capsules daily children under 2 years ask a doctor - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS
-
PRINCIPAL DISPLAY PANEL
DRUG: Colace
GENERIC: Docusate sodium
DOSAGE: CAPSULE
ADMINSTRATION: ORAL
NDC: 70518-3319-0
COLOR: red
SHAPE: OVAL
SCORE: No score
SIZE: 12 mm
IMPRINT: RPC;053
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- Docusate sodium 100mg in 1
INACTIVE INGREDIENT(S):
- D&C RED NO. 33
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- SORBITOL
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- TITANIUM DIOXIDE
-
INGREDIENTS AND APPEARANCE
COLACE
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-3319(NDC:67618-101) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red, white Score no score Shape OVAL Size 12mm Flavor Imprint Code RPC;053 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70518-3319-0 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/29/2021 Labeler - REMEDYREPACK INC. (829572556)