Label: SENNA AND DOCUSATE SODIUM tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 11534-134-05, 11534-134-60 - Packager: Sunrise Pharmaceutical Inc
- Category: HUMAN OTC DRUG LABEL
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 August 2, 2013
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- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS AND USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
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DOSAGE AND ADMINISTRATION
Drink with a full glass of water with each dose
Adults and children 12 years and over take 2 - 4 tablets daily Children 6 to under 12 years take 1 - 2 tablets daily Children 2 to under 6 years take up to 1 tablet daily Children under 2 years of age Ask a doctor OTHER INFORMATION
Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM.
Do not use if the imprinted safety seal under cap is missing or damaged.
Store at at 25°C (77°F); excursions permitted between 15(-30(C (59(-86(F)
Keep tightly closed.
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENNA AND DOCUSATE SODIUM
senna and docusate sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11534-134 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND Size 10mm Flavor Imprint Code S134 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11534-134-60 60 in 1 BOTTLE 2 NDC:11534-134-05 57603 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/26/2007 Labeler - Sunrise Pharmaceutical Inc (168522378)