Label: LAXATIVE- sennosides tablet
- NDC Code(s): 0363-9978-24, 0363-9978-48, 0363-9978-90
- Packager: WALGREENS
- 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 April 19, 2023
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- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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Warnings
Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks.
Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.
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INGREDIENTS AND APPEARANCE
LAXATIVE
sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9978 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 25 mg Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) STARCH, CORN (UNII: O8232NY3SJ) KAOLIN (UNII: 24H4NWX5CO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FERRIC OXIDE RED (UNII: 1K09F3G675) RAW SUGAR (UNII: 8M707QY5GH) TALC (UNII: 7SEV7J4R1U) ACACIA (UNII: 5C5403N26O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) STEARIC ACID (UNII: 4ELV7Z65AP) MALTODEXTRIN (UNII: 7CVR7L4A2D) SHELLAC (UNII: 46N107B71O) Product Characteristics Color blue Score no score Shape ROUND Size 11mm Flavor Imprint Code TCL083 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9978-48 4 in 1 CARTON 04/15/2023 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0363-9978-24 2 in 1 CARTON 04/15/2023 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0363-9978-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/15/2023 Labeler - WALGREENS (008965063) Registrant - TIME CAP LABORATORIES INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES INC. 037052099 manufacture(0363-9978)