FDA Label for Senna Laxative
View Indications, Usage & Precautions
Senna Laxative Product Label
The following document was submitted to the FDA by the labeler of this product P & L Development, Llc. 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.
Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Purpose
Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement within 6- 12 hours.
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
- 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 and over | 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 tablets once a day | 1 tablet twice a day |
children under 2 years | ask a doctor | ask a doctor |
Other Information
- each tablet contains: calcium 30 mg
- store at 25o C (77o F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil*, silicon dioxide*, sodium lauryl sulfate*, stearic acid*, talc*, triacetin*
*contains one or more of these ingredients
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Senokot®†
regular strength
natural laxative
sennosides 8.6 mg
laxative
- natural vegetable laxative ingredient
- gentle, dependable
- overnight relief
tablets
†This product is not manufactured or distributed by Aviro Health L.P., distributor of Senokot®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
Product Label
READYinCASE Regular Strength Laxative
* Please review the disclaimer below.