Medique Medi-lax Enteric Coated: Package Insert and Label Information

MEDIQUE MEDI-LAX ENTERIC COATED- bisacodyl tablet, sugar coated
Unifirst First Aid Corporation

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.

Drug Facts

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Uses

• for the temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use if you cannot swallow without chewing.

Ask a doctor before use if you have

• stomach pain, nausea or 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 use within 1 hour after taking an antacid or milk
• it may cause stomach discomfort, faintness or cramps

Stop use and ask a doctor if you

• have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
• need to use a laxative for more than 1 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 (1-800-222-1222) right away.

Directions

Adults and children 12 years and older: 1 to 3 tablets in a single daily dose

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

Other information

• store between 68º to 77ºF (20º to 25ºC)
• tamper evident sealed blister pack(s)
• do not use if a blister unit is torn, broken or shows any signs of tampering

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 or comments

Call 1-800-634-7680

Medique Medi-lax Label

Medique®

Medi-lax

Stimulant Laxative

Bisacodyl Delayed-Release Tablets USP, 5 mg

*Compare to the active ingredients in Ducolax®

Enteric Coated Tablets

Tamper Evident Blister Pack

25 Tablets

MEDIQUE MEDI-LAX ENTERIC COATED bisacodyl 5 mg tablet, sugar coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-859 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (DEACETYLBISACODYL) BISACODYL 5 mg

Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 PROPYLENE GLYCOL CARNAUBA WAX SHELLAC SODIUM ALGINATE AMMONIA METHYLPARABEN POVIDONE CALCIUM CARBONATE POLYETHYLENE GLYCOL 1000 POLYVINYL ACETATE PHTHALATE D&C YELLOW NO. 10 MAGNESIUM STEARATE POLYDEXTROSE TALC FERROSOFERRIC OXIDE ANHYDROUS LACTOSE TRIACETIN TRIETHYL CITRATE SODIUM BENZOATE SODIUM BICARBONATE SUCROSE STARCH, CORN HYPROMELLOSE, UNSPECIFIED SILICON DIOXIDE ACACIA PROPYLPARABEN DIMETHICONE STEARIC ACID TITANIUM DIOXIDE

Product Characteristics Color orange Score no score Shape ROUND Size 6mm Flavor Imprint Code 5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:47682-859-05 1 BLISTER PACK in 1 BOX contains a BLISTER PACK 1 25 TABLET, SUGAR COATED in 1 BLISTER PACK This package is contained within the BOX (47682-859-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/01/2020

Labeler — Unifirst First Aid Corporation (832947092)

Revised: 03/2020 Unifirst First Aid Corporation