Label: SENNOSIDE 8.6MG tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 70692-112-41 - Packager: Strive Pharmaceuticals 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.
Drug Label Information
Updated November 16, 2020
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
- do not take more than directed
- take with full glass of water
- take preferably at bedtime or as directed by a doctor
Age Starting dosage Maximum dosage adults and children 12 years of age and 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 - INDICATIONS & USAGE
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WARNINGS
Do not use
laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- notice a sudden change in bowel habits that continue 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.
If pregnant or breast-feeding
ask a health professional before use
Keep out of reach of children
Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENNOSIDE 8.6MG
sennoside 8.6mg tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B 8.6 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) HYPROMELLOSES (UNII: 3NXW29V3WO) Product Characteristics Color gray Score no score Shape ROUND (BICONVEX) Size 5mm Flavor Imprint Code S3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-112-41 4 in 1 PACKAGE; Type 0: Not a Combination Product 12/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/20/2018 Labeler - Strive Pharmaceuticals Inc. (080028013)
