Label: SENNA- sennosides a and b tablet
- NDC Code(s): 51824-198-01
- Packager: New World Imports
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredient
Sennosides 8.6 mgClose
Relieves occasional constipation (irregularity)
Generally causes a bowel movement in 6 - 12 hoursClose
Do not use Laxative products for longer than 1 week, unless directed by a doctor
Ask a doctor before using if you have: Stomach pain, nausea, vomiting, or noticed a sudden change in bowel movements that continues over a period of 2 weeks
Stop use ans ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use. These may indicate a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Take preferably at bedtime or as directed by a doctor.
Adults and children over 12 years of age: Starting dosage 2 tablets once a day. Maximum Dosage 4 tablets twice a day.
Children 6 to under 12 years of age: Starting dosage 1 tablets once a day. Maximum Dosage 2 tablets twice a day.
Children 2 to under 6 years of age: Starting dosage 1/2 tablet once a day. Maximum Dosage 1 tablet twice a day.
Children under 2 years of age: Ask a doctorClose
- Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypermellose, maltodextrin, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG), stearic acid, talc, triacetin.
*May also contain.Close
- Package Labeling
Compare to the active ingredient in Senokot
Natural Vegetable Laxative
Standardized Senna Concentrate
100 Senna Tablets
Sennosides 8.6mg each
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-198 Route of Administration ORAL DEA Schedule 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BROWN (Light brown speckled with dark brown) Score no score Shape ROUND (Round) Size 9mm Flavor Imprint Code S3;S8;TCL080 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-198-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 11/11/2010 04/28/2015 Labeler - New World Imports (075372276)