Label: LAXATIVE- bisacodyl tablet
- NDC Code(s): 11822-0327-1, 11822-0327-5, 11822-0327-6
- Packager: Rite Aid
- 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 (in each tablet)
Bisacodyl 5 mgClose
- relieves occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
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 chew or crush tablet(s)
- do not use within 1 hour after taking an antacid or milk
- you may have stomach discomfort, faintness or 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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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 of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor
- Other information
- store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- avoid excessive humidity
- see end flap for expiration date and lot number
- Inactive ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrateClose
- Principal Display Panel
*Compare to the active ingredient in Dulcolax®
bisacodyl USP 5 mg
5 mg EACH
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax®.
30 HUNTER LANE
CAMP HILL, PA 17011
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Rite Aid 44-327
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0327 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (BISACODYL) BISACODYL 5 mg Inactive Ingredients Ingredient Name Strength ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES FERROSOFERRIC OXIDE LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE Product Characteristics Color ORANGE Score no score Shape ROUND Size 6mm Flavor Imprint Code 44;327 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0327-5 1 in 1 CARTON 1 50 in 1 BLISTER PACK 2 NDC:11822-0327-1 1 in 1 CARTON 2 100 in 1 BOTTLE, PLASTIC 3 NDC:11822-0327-6 1 in 1 CARTON 3 200 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 03/25/2002 Labeler - Rite Aid (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(11822-0327) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(11822-0327)