MEDIQUE MEDI-LAX- bisacodyl tablet, delayed release

Medique Medi-lax by

Drug Labeling and Warnings

Medique Medi-lax by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation, Future Pak. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Bisacodyl 5mg

Purpose

Stimulant laxative

Uses

• temporarily relieves occasional constipation and irregularity
• generally produces bowel movement in 6 to 12 hours

Warnings

Do not chew tablets, give to children under 12 years or to persons who cannot swallow without chewing.

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• a sudden change in bowel habits that lasts more than 2 weeks

When using this product

• do not chew or crush tablet(s)
• do not take within 1 hour after taking an antacid or milk
• you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if you

• have rectal bleeding or if you fail to have a bowel movement after using this product. These could be signs of a serious
  condition.
• need to use a laxative for more than one week

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

take with a glass of water

adults and children 12 years and over: take 1 to 3 tablets in a single daily dose, or as directed by a doctor

children under 12 years: do not give to children under 12 years of age

Other information

• store at 25ºC (77ºF) excursions permitted between 15º-30ºC (59º-86ºF)
• tamper evident sealed blister pack(s)
• do not use if a blister unit is torn, broken or shows any signs of tampering
• protect from moisture and excessive humidity

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, FD&C Yellow #6 aluminum lake, gelatin, iron oxide black (ferrosoferric oxide), iron oxide red, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions or comments? Call 1-800-634-7680

Medique Medi-lax Label

Medique ®

Medi-lax

Stimulant Laxative

Bisacodyl Delayed-Released USP, 5 mg

Compare to the Active Ingredient in Dulcolax ®

Registered Trademark of Boehringer Ingelheim

Tamper Evident Blister Pack

25 Tablets

Easy To Swallow

Enteric Coated Tablets

INGREDIENTS AND APPEARANCE

MEDIQUE MEDI-LAX 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-889
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
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ACACIA (UNII: 5C5403N26O)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	orange (orange)	Score	no score
Shape	ROUND (ROUND)	Size	3mm
Flavor		Imprint Code	TCL;003
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-889-05	1 in 1 BOX	12/30/2008	07/02/2021
1		25 in 1 BLISTER PACK; 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	12/30/2008	07/02/2021

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Future Pak		087737672	relabel(47682-889) , repack(47682-889)