Label: SENNA TABS- senna tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 16103-363-08, 16103-363-11 - Packager: Pharbest 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 January 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
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Directions
- take preferably at bedtime or as directed by a doctor
age
starting dosage
maximum dosage
Adults and children 12 years 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
½ 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
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INGREDIENTS AND APPEARANCE
SENNA TABS
senna tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-363 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) TALC (UNII: 7SEV7J4R1U) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code S8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16103-363-08 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/03/2018 2 NDC:16103-363-11 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/03/2018 Labeler - Pharbest Pharmaceuticals, Inc. (557054835) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc 557054835 analysis(16103-363) , manufacture(16103-363) , pack(16103-363) , label(16103-363)
