Active Ingredient (In Each Tablet)
Bisacodyl USP, 5 mg
Laxative Tablet, Delayed Release
FDA Label NDC 11822-0790
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Laxative (NDC 11822-0790). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Uses
- for relief of occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
Do Not Use
if you cannot swallow without chewing.
Ask A Doctor Before Use If You Have
- stomach pain, nausea or vomiting
- a sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
- do not use within 1 hour after taking an antacid or milk
- do not chew or crush tablet(s)
- you may have stomach discomfort, faintness and cramps
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
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
- do not take more than directed
- take with a glass of water
| adults and children 12 years and over | take 1 to 3 tablets in a single daily dose |
| children 6 to under 12 years | take 1 tablet in a single daily dose |
| children under 6 years | ask a doctor |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- avoid excessive humidity
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
acacia, ammonium hydroxide, black iron oxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, sodium citrate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 11822-0790-5
Compare to the active ingredient in
Dulcolax®Laxative Tablets*
FREE
FROM
PARABEN
FREE
LAXATIVE
BISACODYL USP, 5 mg
STIMULANT LAXATIVE
Gentle, dependable constipation relief
Comfort Coated Tablets
ACTUAL SIZE
25
TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner
of the registered trademark Dulcolax® Laxative Tablets. 50844 ORG092279056
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www,riteaid.com
SATISFACTION
GUARANTEE
If you're not satisfied, we'll
happily refund your money
Rite Aid 44-790 (Rite Aid 44 790 1)
* Please review the disclaimer below.
