Label: CAREALL SENNA-S LAXATIVE- docusate sodium, sennosides tablet
- NDC Code(s): 51824-054-01, 51824-054-02
- Packager: New World Imports, 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 October 1, 2019
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- Active Ingredient
Do not use:
This product is you are presently 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, nausea, vomiting, a sudden change in bowel movements that persists over 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 could be signs of a serious condition.
- Keep out of reach of children.
- taken preferably at bedtime or as directed by a doctor. If you don't have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable.
Age Starting Dose Maximum Dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day children 2 to 6 years of age 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor
- each tablet contains: sodium 6 mg/tablet LOW SODIUM
- each tablet contains: calcium 20 mg/tablet
- store at 15°-30°C (59°-86°F),in well closed containers
- do not use if imprinted safety seal under cap is broken or missing
- *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Senokot S.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CAREALL SENNA-S LAXATIVE
docusate sodium, sennosides tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-054 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 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) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:51824-054-02 24 in 1 CASE 04/18/2016 1 NDC:51824-054-01 60 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 04/18/2016 Labeler - New World Imports, Inc. (075372276)