NEW CORRECT- bisacodyl tablet, delayed release 
Time-Cap Labs, 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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Each tablet contains: Bisacodyl 5 mg

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks.

Ask a doctor or pharmacist before use if you are taking any other drug.  Take this product two or more hours before or after other drugs.  Laxatives may affect how other drugs work.

Warnings:

Do not use for longer than one week; when abdominal pain, nausea or vomiting are present,; in children under 6 years of age; in persons who cannot swallow without chewing

Warnings:

Do not use for longer than one week; when abdominal pain, nausea or vomiting are present,; in children under 6 years of age; in persons who cannot swallow without chewing

Directions - DO NOT CHEW TABLETS

ADULTS AND CHILDREN 12 YEAR AND OVER - 1 -3 TABLETS ONCE A DAY

CHILDREN 6 TO 11 YEARS - 1 TABLET ONCE DAILY

CHILDREN UNDER 6 YEARS - ASK A DOCTOR

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS:  Acacia, Calcium Sulfate Anhydrous, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D-C Red#7 Calcium Lake, Hypromellose Phthalate, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow, Kaolin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide, Triacetin

Uses:  Relieves occasional constipation; generally produces bowel movement in 6-12 hours.

Uses:  Relieves occasional constipation; generally produces bowel movement in 6-12 hours. Laxative

QUESTIONS OR COMMENTS? TIME-CAP LABS, INC. 7 MICHAEL AVE FARMINGDALE NY 11735

STOP USE AND ASK A DOCTOR IF:

You have rectal bleeding, you fail to have a bowel movement after use of this product.  THESE MAY INDICATE A SERIOUS CONDITION.

When using this product; do not take dose within one hour of taking an antacid or milk; you may experience abdominal discomfort, faintness and cramps.

BISACODYL D-R TABLETS 5 MG 246RBULK LABEL

NEW CORRECT 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-046
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)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
FERROUS OXIDE (UNII: G7036X8B5H)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code TCL057
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-046-00100000 in 1 CARTON; Type 0: Not a Combination Product08/06/200801/20/2019
2NDC:49483-046-5115 in 1 BLISTER PACK; Type 0: Not a Combination Product08/06/200801/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/06/200801/20/2019
Labeler - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time-Cap Labs, Inc037052099manufacture(49483-046)

Revised: 8/2018
 
Time-Cap Labs, Inc