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NEW CORRECT

Time-Cap Labs, Inc




FULL PRESCRIBING INFORMATION

Active ingredient

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:

Directions - DO NOT CHEW TABLETS

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



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

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

Purpose

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 MGNEW CORRECT

NEW CORRECT

BISACODYL TABLET, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49483-046
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bisacodyl Bisacodyl 5 mg

Inactive Ingredients

Ingredient Name Strength
ACACIA
CALCIUM SULFATE ANHYDROUS
carnauba wax
SILICON DIOXIDE
STARCH, CORN
D&C RED NO. 7
hypromellose phthalate (31% phthalate, 40 CST)
FERROUS OXIDE
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
KAOLIN
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
povidone
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCROSE
talc
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
pink 8 mm TCL057 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49483-046-00 100000 in 1 CARTON
2 NDC:49483-046-51 15 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2008-08-06


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Be sure to consult your doctor before taking any medication!
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