Label: SENNA-LAX- sennosides tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68788-6442-1, 68788-6442-3, 68788-6442-8 - Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-6522
- 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 June 23, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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DOSAGE & ADMINISTRATION
Directions
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- preferable at bedtime or a directed by a doctor
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- adults and children 12 years of age and older: 2 tablets once a day: maximum of 4 tablets once a day
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- children (6-12 years) 1tablet once a day: maximum 2 tablets once a day
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- children (2-6 years) ½ tablet once a day: maximum 1 tablet once a day
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- children under 2 years of age: Ask a doctor
Other information
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- Store at room temperature, USP
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- Each tablet contains: Calcium 20 mg
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Inactive ingredient
Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil and Polyethylene Gycol
Questions or comments? (800) 616-2471
Tamper Evident:
Do not use if sealed blister units are broken or damaged.
Product color may slightly vary due to natural changes of ingredients
Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.comDistributed By:
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150
Rev. 10/15
Repackaged By: Preferred Pharmaceuticals Inc.
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SENNA-LAX
sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-6442(NDC:0904-6522) 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) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM SILICATE (UNII: 9B9691B2N9) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Product Characteristics Color BROWN (Mottled brown) Score no score Shape ROUND Size 9mm Flavor Imprint Code 1122 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-6442-3 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/29/2016 2 NDC:68788-6442-1 100 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/29/2016 3 NDC:68788-6442-8 120 in 1 BLISTER PACK; Type 0: Not a Combination Product 06/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/29/2016 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-6442)
