Label: BEKUNIS NATURES GENTLE STIMULANT LAXATIVE- sennosides a and b tablet, sugar coated
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Contains inactivated NDC Code(s)
NDC Code(s): 42982-4441-1 - Packager: roha arzneimittel GmbH
- 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 February 13, 2011
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- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients calcium carbonate, carmellose sodium, gelatine, gum arabic, glucose syrup dry substance, lactose, Macrogol 6000, magnesium stearate, methyl acrylic acid-ethyl acrylate copolymer (1:1), methylated silicon dioxide, microcrystalline celluclose, montan glycol wax, polysorbate 80, stearic acid, sucrose, talcum, titanium dioxide.
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INGREDIENTS AND APPEARANCE
BEKUNIS NATURES GENTLE STIMULANT LAXATIVE
sennosides a and b tablet, sugar coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42982-4441 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES A AND B 20 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GELATIN (UNII: 2G86QN327L) ACACIA (UNII: 5C5403N26O) DEXTROSE (UNII: IY9XDZ35W2) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (WHITE GRAY) Score no score Shape OVAL Size 10mm Flavor Imprint Code ; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42982-4441-1 40 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/10/2011 Labeler - roha arzneimittel GmbH (319896957)