Label: PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH- sennosides tablet, film coated
- NDC Code(s): 63187-683-00, 63187-683-30, 63187-683-60, 63187-683-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 51645-851
- 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 1, 2019
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
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 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 under 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
- Other information
- Inactive ingredients
- Questions?
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Principal Display Panel
NDC 63187-683-00
PlusPHARMA
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
Senna
Standardized Senna Concentrate
8.6 mg Sennosides Each
Natural Vegetable Laxative Ingredient
*Compare to Senokot®
Product color may vary slightly due to nature of ingredients.
*Plus Pharma is not affiliated with the owner of the registered trademark Senokot®.
100 TABLETS
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INGREDIENTS AND APPEARANCE
PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH
sennosides tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-683(NDC:51645-851) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SODIUM SULFATE (UNII: 0YPR65R21J) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color brown Score 2 pieces Shape ROUND (Biconvex) Size 9mm Flavor Imprint Code GPI;W2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-683-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2016 2 NDC:63187-683-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2016 3 NDC:63187-683-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2016 4 NDC:63187-683-00 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/27/2006 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-683) , RELABEL(63187-683)
