ALOPHEN - bisacodyl tablet, coated 
NUMARK BRANDS, 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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Drug Facts

Active ingredient (in each enteric coated tablet)Purpose
Bisacodyl 5 mgLaxative

Use

for the relief of occasional constipation and irregularity. This product generally produces a bowel movement in 6-12 hours.

Warnings

Do not use

Ask a doctor before use if you have

a sudden change in bowel habits over a period of 2 weeks.

When using this product

Stop use and ask a doctor if

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over1-3 tablets in a single daily dose
children 6 to under 12 years of age1 tablet in a single daily dose
children under 6 years of ageconsult a doctor

Other information

store at temperature not above 86° F(30 C)

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

call 1-800-214-2379

PRINCIPAL DISPLAY PANEL

NDC 69846-140-01

Now Smaller,
Easier to Swallow


Alophen®
(Bisacodyl USP)

Comfort Coated
Stimulant Laxative

Gentle, Effective
Overnight Relief


100 Tablets, 5 mg. each

Do not use if printed "SEALED FOR YOUR PROTECTION" inner seal is broken or missing.

Dist. by: Numark Brands, Inc.                57001
EDISON, NJ 08818    1-800-214-2379  Rev. 4/21

LOT #

EXP. DATE
 

Carton

NDC 69846-140-01

Now Smaller, Easier to Swallow

Alophen®
(Bisacodyl USP)

Comfort Coated
Stimulant Laxative

Gentle, Effective
Overnight Relief


100 Tablets, 5 mg. each

REFER TO OUTER CARTON FOR FULL INFORMATION

Distributed by: Numark Brands, Inc.
EDISON, NJ 08818    1-800-214-2379     57000    Rev. 1/21

LOT #

EXP. DATE

Label
ALOPHEN  
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69846-140
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)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
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)  
Anhydrous Lactose (UNII: 3SY5LH9PMK)  
Magnesium Stearate (UNII: 70097M6I30)  
Methylparaben (UNII: A2I8C7HI9T)  
Polydextrose (UNII: VH2XOU12IE)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
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)  
Product Characteristics
ColorYELLOW, ORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code TCL;003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69846-140-011 in 1 CARTON04/15/1907
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/15/1907
Labeler - NUMARK BRANDS, INC (080184668)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004manufacture(69846-140)

Revised: 12/2021
Document Id: c0ba89be-5af4-46bf-b629-6b0e36267785
Set id: 622fda65-cead-ae70-0f7d-b202d49192af
Version: 4
Effective Time: 20211228
 
NUMARK BRANDS, INC