Label: SENNA PLUS- sennosides 8.6mg and docusate sodium 50mg tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 66424-378-02 - Packager: SDA Laboratories, 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 April 15, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (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
- if you are taking mineral oil, 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
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
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INGREDIENTS AND APPEARANCE
SENNA PLUS
sennosides 8.6mg and docusate sodium 50mg tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66424-378 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code PH32 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66424-378-02 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/15/2019 Labeler - SDA Laboratories, Inc. (948067889) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 manufacture(66424-378) , analysis(66424-378) , pack(66424-378) , label(66424-378)