BISACODYL STIMULANT LAXATIVE- bisacodyl tablet, coated 
Raritan 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.

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DRx. CHOICE® Stimulant Laxative 25 Coated Tablets

Active ingredient (in each tablet)

Bisacodyl, USP 5 mg

Purpose

Stimulant laxative

Use

for relief of occasional constipation and irregularity
this product generally produces a 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

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

When using this product

it may cause stomach discomfort, faintness and cramps
do not chew or crush tablet(s)
do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

you have rectal bleeding or fail to have bowl movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

If pregnancy 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 at (1-800-222-1222).

Directions

take with a glass of water

adults and children 12 years of age and over 

1 to 3 tablets in a single daily dose 

children 6 to under 12 years of age

1 tablet in a single daily dose

children under 6 years of age

ask a doctor

Other information

store at room temperature
Protect from excessive humidity

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow No. 10, FD&C yellow No. 6, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

Questions or comments?

1-866-467-2748

Principal Display Panel

NDC# 68163-116-25

*Compare to the Active Ingredient in Dulcolax® Tablets

Bisacodyl Laxative

Bisacodyl, USP 5 mg/Stimulant Laxative

Gentle, Overnight relief constipation relief

25 Coated Tablets

*This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Dulcolax® Tablets.

TAMPER EVIDENT: Do not use if any individual unit is broken or open.

IMPORTANT: Keep this carton for future reference on full labeling.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

DRx Choice Bisacodyl Laxative
BISACODYL  STIMULANT LAXATIVE
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-116
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)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
RAW SUGAR (UNII: 8M707QY5GH)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code RP116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-116-251 in 1 CARTON10/29/2019
125 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/29/2019
Labeler - Raritan Pharmaceuticals Inc (127602287)

Revised: 9/2023
Document Id: 6eb07854-d4a5-4bb2-b0fa-1a28a2c02f71
Set id: b99c1a6d-3034-4822-8540-210179c06857
Version: 5
Effective Time: 20230901
 
Raritan Pharmaceuticals Inc