Search by Drug Name or NDC

NDC 47682-0859-05 Medique Medi-lax Enteric Coated 5 mg/1 Details

Medique Medi-lax Enteric Coated 5 mg/1

Medique Medi-lax Enteric Coated is a ORAL TABLET, SUGAR COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. The primary component is BISACODYL.

MedlinePlus Drug Summary

Bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 47682-0859-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl

Product Information

NDC	47682-0859
Product ID	47682-859_da5b0190-06c5-5f11-e053-2995a90af073
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Medique Medi-lax Enteric Coated
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bisacodyl 5 mg
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, SUGAR COATED
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	BISACODYL
Labeler Name	Unifirst First Aid Corporation
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 47682-0859-05 (47682085905)

Pricing Information	N/A
NDC Package Code	47682-859-05
Billing NDC	47682085905
Package	1 BLISTER PACK in 1 BOX (47682-859-05) / 25 TABLET, SUGAR COATED in 1 BLISTER PACK
Marketing Start Date	2020-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a229acfa-4c5c-9cc3-e053-2a95a90a5c66 Details

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

INGREDIENTS AND APPEARANCE

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

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

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
TALC (UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SUCROSE (UNII: C151H8M554)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ACACIA (UNII: 5C5403N26O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHELLAC (UNII: 46N107B71O)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
AMMONIA (UNII: 5138Q19F1X)
POVIDONE (UNII: FZ989GH94E)
CALCIUM CARBONATE (UNII: H0G9379FGK)
METHYLPARABEN (UNII: A2I8C7HI9T)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47682-859-05	1 in 1 BOX	07/01/2020
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 3/2022

Document Id: da5b0190-06c5-5f11-e053-2995a90af073

Set id: a229acfa-4c5c-9cc3-e053-2a95a90a5c66

Version: 3

Effective Time: 20220316