ALOPHEN- bisacodyl tablet, coated

Alophen by

Drug Labeling and Warnings

Alophen by is a Otc medication manufactured, distributed, or labeled by NUMARK BRANDS, INC, ULTRA SEAL CORPORATION, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient (in each enteric coated tablet): Purpose
• Bisacodyl: Laxative

Use

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

Warnings

Do not use

• when abdominal pain, nausea, or vomiting are present
• this product for more than 1 week unless directed by a doctor
• this product within 1 hour after taking an antacid or milk
• for children under 6 years of age
• for persons who can not swallow without chewing

Ask a doctor before use if you have

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

When using this product

• do not chew the tablets
• it may cause abdominal discomfort, faintness, and cramps

Stop use and ask a doctor if

• rectal bleeding occurs
• there is failure to have a bowel movement after use of a laxative. These may indicate a serious condition.

PREGNANCY OR BREAST FEEDING

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

• do not chew tablets

• adults and children 12 years of age and over: 1-3 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: consult a doctor

Other information

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

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10, FD&C Yellow #6, gelatin, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, povidone, pharmaceutical glaze, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide 

Questions?

call 1-800-331-0221

PRINCIPAL DISPLAY PANEL

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 LABORATORIES INC.
EDISON, NJ 08818    Rev. 3/12    57001

LOT #

EXP. DATE

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 LABORATORIES INC.
EDISON, NJ 08818      Rev. 3/12     57000

LOT #

EXP. DATE

INGREDIENTS AND APPEARANCE

ALOPHEN  
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69846-140
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bisacodyl (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	Bisacodyl	5 mg

Inactive Ingredients
Ingredient Name	Strength
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 (UNII: 2G86QN327L)
Ferric Oxide Red (UNII: 1K09F3G675)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
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)

Product Characteristics
Color	YELLOW, ORANGE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	TCL;003
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69846-140-01	1 in 1 CARTON	04/15/1907
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/15/1907

Labeler - NUMARK BRANDS, INC (080184668)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	manufacture(69846-140)