HEALTH SENSE DUCODYL- bisacodyl tablet, coated 
Prime Marketing, LLC

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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health sense 441

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses

  • relieves occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

  • for more than one week unless directed by a doctor
  • if you cannot swallow without chewing
  • within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

  • abdominal pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts longer than 2 weeks

When using this product

  • abdominal discomfort, faintness, or cramps may occur

Stop use and ask a doctor

  • if you have no bowel movement within 12 hours
  • if you have rectal bleeding
  • these could be signs of a serious condition

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
  • swallow whole, do not chew or crush
  • take recommended dose in a single daily dose
  • take with water
adults and children 12 years and overtake 1-3 (usually 2) tablets daily
children 6-11 years1 tablet daily
children under 6consult a doctor

Other information

  • store at room temperature
  • avoid excessive humidity
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Inactive ingredients

Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D&C Yellow #10 Lake, FD&C Yellow NO. 6 Lake, Hypromellose, Iron Oxide Black, Lactose, Magnesium Stearate, Methylparaben, PEG, Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben, Propylene Glycol, Povidone, Shellac, Simethicone, Silica, Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate, Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate, Wax.

Package Label

NDC 62107-030-01

Health Sense

Ducodyl

BISACODYL 5MG

LAXATIVE

Enteric Coated

Stimulant Laxative
100 Tablets

hs441

HEALTH SENSE DUCODYL 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62107-030
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
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)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62107-030-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2014
2NDC:62107-030-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/01/200606/01/2021
Labeler - Prime Marketing, LLC (071371194)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
NameAddressID/FEIBusiness Operations
Geri-Care Pharmaceutical Corp611196254repack(62107-030)

Revised: 12/2019
 
Prime Marketing, LLC