Label: NATURAL VEGETABLE LAXATIVE AND STOOL SOFTENER- docusate sodium and sennosides tablet
- NDC Code(s): 21130-219-03
- Packager: BETTER LIVING BRANDS LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 25, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- take preferably at bedtime or as directed by a doctor
age starting dose maximum dosage adults and children 12 years of age and over 2 tablets once a day
4 tablets twice a day children 6 to under 12
years1 tablet once a day 2 tablets twice a day children 2 to under 6
years½ tablet once a day
1 tablet twice a day children under 2 years ask a doctor
ask a doctor - OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide
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INGREDIENTS AND APPEARANCE
NATURAL VEGETABLE LAXATIVE AND STOOL SOFTENER
docusate sodium and sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-219 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color orange Score no score Shape ROUND Size 9mm Flavor Imprint Code TCL081 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-219-03 1 in 1 CARTON 12/14/2023 1 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 12/14/2023 Labeler - BETTER LIVING BRANDS LLC. (009137209) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(21130-219)