Label: COLACE- docusate sodium capsule
-
NDC Code(s):
67618-101-01,
67618-101-10,
67618-101-30,
67618-101-52, view more67618-101-60
- Packager: Atlantis Consumer Healthcare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 26, 2023
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- Official Label (Printer Friendly)
- DESCRIPTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- ASK DOCTOR/PHARMACIST
- DO NOT USE
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PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In caseof overdose, get medical help or contact a Poison Control Center rightaway.
Directions: Take only by mouth. Dosesmay be taken as a single daily dose or in divided doses.
adults and children 12 yearsand over take 1-3 capsules daily children 2 to under 12 yearsof 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
-
INGREDIENTS AND APPEARANCE
COLACE
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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:67618-101-10 2 in 1 CARTON 01/30/1997 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:67618-101-30 1 in 1 CARTON 01/30/1997 2 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:67618-101-60 1 in 1 CARTON 01/30/1997 3 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:67618-101-01 1 in 1 CARTON 01/17/2022 4 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:67618-101-52 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/30/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 01/30/1997 Labeler - Atlantis Consumer Healthcare, Inc. (118983925) Registrant - Atlantis Consumer Healthcare, Inc. (118983925)