FDA Label for Senna
View Indications, Usage & Precautions
Senna Product Label
The following document was submitted to the FDA by the labeler of this product Aace Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Senna Tablets
Sennosides 8.6 mg
AACE Pharmaceuticals, Inc.
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.
Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Purpose
Laxative
Uses
- relieves occasional constipation (irregularity)
- this product generally produces a bowel movement in 6 to 12 hours
Do Not Use
- laxative products for longer than 1 week unless directed by a doctor
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
Stop Use And Ask A Doctor If
you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take preferably at bedtime or as directed by a doctor
age | starting dosage | maximum dosage |
adults and children 12 years of age or older | 2 tablets once a day | 4 tablets twice a day |
children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
children 2 to under 6 years | 1/2 tablet once a day | 1 tablet twice a day |
children under 2 years | ask a doctor | ask a docto |
Other Information
- each tablet contains: calcium 4 mg, sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid
Principal Display Panel
†Compare to the active ingredient in Senokot®
Senna Tablets
Sennosides 8.6 mg
Natural Vegetable Laxative
Gentle, Overnight Relief of Constipation
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by:
AACE Pharmaceuticals, Inc. Fairfield, NJ 07004
aacepharma.com
†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®.
* Please review the disclaimer below.