Label: LAXATIVE AND STOOL SOFTENER- docusate sodium, sennosides tablet
- NDC Code(s): 49035-360-30
- Packager: EQUATE (Wal-Mart Stores, 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.
Updated May 26, 2021
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- Active ingredients (in each tablet)
Do not use
- if you are now taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
- stomach pain
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
Stop use and ask a doctor if
you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
- take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage adults and children 12 years of age or over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Compare to Senokot® active ingredients†
Laxative + Stool Softener
Docusate sodium, 50 mg
Sennosides, 8.6 mg
- Effective, Comfortable
- Overnight relief
- Gentle, dependable
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot-S®.
DISTRIBUTED BY: Wal-Mart Inc.,
Bentonville, AR 72716
- Product Labeling
INGREDIENTS AND APPEARANCE
LAXATIVE AND STOOL SOFTENER
docusate sodium, sennosides tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-360 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code PSD22 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-360-30 1 in 1 BOX 09/01/2020 1 30 in 1 BOTTLE, PLASTIC; 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 09/01/2020 Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)