Label: GOOD REMEDIES GENTLE LAXATIVE- bisacodyl tablet, coated
- NDC Code(s): 70692-167-52
- Packager: Strive Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 10, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
Do not use • if you cannot swallow without chewing.
Ask a doctor before use if you have
• stomach pain, nausea or vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeksWhen using this product
• it may cause stomach discomfort, faintness and cramps • do not chew or crush tablet(s) • do not use within 1 hour after taking an antacid or milkStop use and ask a doctor if
• you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. • you need to use a laxative for more than 1 weekIf pregnant or breast-feeding, ask a health professional before use.
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Directions
• do not take more than directed
• take with a glass of wateradults and children 12 years of age and over 1 to 3 tablets in a single daily dose. It is recommended to start with the lowest dose (1 tablet) increasing the next day as needed children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years ask a doctor - Other information
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Inactive ingredients
acacia gum, calcium carbonate, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, gelatin, glycerol monostearate, hypromellose, iron oxide red, magnesium stearate, methacrylic acid co-polymer type C, microcrystalline cellulose, polyethylene glycol, precipitated silica, silicon dioxide, sodium methylparaben, sodium propylparaben, sodium starch glycolate, starch, sucrose, talcum, titanium dioxide, triethyl citrate
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SPL UNCLASSIFIED SECTION
Compare to the active ingredient of Dulcolax® Laxative Tablets*
Gentle, dependable constipation relief
*This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets.
READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY:
Strive Pharmaceuticals, Inc.
East Brunswick, NJ 08816Product of India
CT7069216752 REV.00-072023
- Packaging
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INGREDIENTS AND APPEARANCE
GOOD REMEDIES GENTLE LAXATIVE
bisacodyl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-167 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 ACACIA (UNII: 5C5403N26O) CALCIUM CARBONATE (UNII: H0G9379FGK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color orange Score no score Shape ROUND Size 6mm Flavor Imprint Code G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-167-52 1 in 1 CARTON 11/10/2023 1 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 Drug 505G(a)(3) 11/10/2023 Labeler - Strive Pharmaceuticals Inc. (080028013)
