Label: LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-296-24 - Packager: QUALITY CHOICE (Chain Drug Marketing Association)
- 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 November 11, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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.
- Directions
- Other information
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Inactive ingredients
acacia, calcium phosphate dihydrate, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, 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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Principal Display Panel
*Compare to the active ingredient in ex-lax® MAXIMUM STRENGTH
Maximum Strength
Laxative
Stimulant Laxative
Sennosides USP, 25 mg
Gentle, Dependable Overnight Relief
Tablets
*This product is not manufactured or distributed by GlaxoSmithKline Ex-Lax®.plc, distributor of ex-lax®.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
- Product Label
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INGREDIENTS AND APPEARANCE
LAXATIVE PILLS MAXIMUM STRENGTH
sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-296 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 ACACIA (UNII: 5C5403N26O) CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) KAOLIN (UNII: 24H4NWX5CO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MALTODEXTRIN (UNII: 7CVR7L4A2D) 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:63868-296-24 24 in 1 CARTON 08/31/2018 1 1 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 08/31/2018 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)