Label: COLACE- docusate sodium capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-2337-2 - Packager: Physicians Total Care, 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 March 29, 2010
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts Colace 100 mg Active ingredient (in each capsule)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- Other Information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLACE
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-2337(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) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) gelatin (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) polyethylene glycol 400 (UNII: B697894SGQ) propylene glycol (UNII: 6DC9Q167V3) sorbitol (UNII: 506T60A25R) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color RED (Two-toned- opaque light beige and clear red) Score no score Shape OVAL Size 1mm Flavor Imprint Code RPC;053 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-2337-2 1 in 1 CARTON 1 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/08/2011 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel