Label: CARTERS LITTLE PILLS SODIUM-FREE- bisacodyl tablet, delayed release
- NDC Code(s): 10237-906-25, 10237-906-75
- Packager: Church & Dwight Co., Inc.
- 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 January 7, 2023
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- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Principal Display
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INGREDIENTS AND APPEARANCE
CARTERS LITTLE PILLS SODIUM-FREE
bisacodyl tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-906 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code C;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-906-25 1 in 1 CARTON 06/01/2011 11/14/2018 1 25 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:10237-906-75 3 in 1 CARTON 06/01/2011 11/14/2018 2 25 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/01/2011 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Canada Corp. 253933600 manufacture(10237-906)