Rite Aid 44-327

Rite Aid 44-327

Drug Labeling and Warnings

Drug Details

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LAXATIVE- bisacodyl tablet, sugar coated 
Rite Aid Corporation

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.

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Rite Aid 44-327

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses

  • for relief of occasional constipation and irregularity 
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

if you cannot swallow without chewing.

Ask a doctor before use if you have

  • a sudden change in bowel habits that lasts more than 2 weeks
  • stomach pain, nausea or vomiting

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 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

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 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, silica, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal Display Panel

RITE
AID
®
PHARMACY

*Compare to the active ingredient
in Dulcolax® Laxative Tablets

laxative
bisacodyl USP 5 mg
stimulant laxative

gentle, dependable
constipation relief

enteric coated

ACTUAL SIZE

200 TABLETS
5 mg EACH

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax® Laxative Tablets
50844       REV0119A32706

DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011

IF YOU'RE NOT
SATISFIED, WE'LL
HAPPILY REFUND
YOUR MONEY.

44-327

44-327

LAXATIVE 
bisacodyl tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11822-0327
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
AMMONIA (UNII: 5138Q19F1X)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11822-0327-61 in 1 CARTON03/25/2002
125 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 11822-0327-52 in 1 CARTON03/25/2002
225 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 11822-0327-71 in 1 CARTON03/25/2002
3200 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/25/2002
Labeler - Rite Aid Corporation (014578892)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(11822-0327)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(11822-0327)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(11822-0327)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(11822-0327)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(11822-0327)

Revised: 7/2019
 
Rite Aid Corporation


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