WOMENS GENTLE LAXATIVE- bisacodyl capsule, gelatin coated

WOMENS GENTLE LAXATIVE by

Drug Labeling and Warnings

WOMENS GENTLE LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Walgreens. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each softgel)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

• for 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 softgel(s)
• it may cause stomach discomfort, faintness and cramps
• do not use within 1 hour after taking an antacid or milk

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.
• you 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 right away.

Directions

take with a glass of water

• adults and children 12 years and over: 1 to 3 softgels in a single daily dose
• children 6 to under 12 years of age: 1 softgel in a single daily dose
• children under 6 years of age: ask a doctor

Other information

• store at controlled room temperature 15-30°C (59-86°F)
• avoid excessive humidity

Inactive ingredients

D&C Red 33, FD&C Yellow 6, gelatin, glycerin, polyethylene glycol-400, povidone (PVP K-30), propylene glycol, purified water, sorbitol, titanium dioxide

Questions?

Call 1-888-333-9792 Monday-Friday 9AM-5PM EST

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DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 25 Softgel Bottle Carton

Walgreens

NDC: 0363-3011-25

Laxative Softgels

BISACODYL USP 5 mg / STIMULANT LAXATIVE

25

SOFTGELS

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

WOMENS GENTLE LAXATIVE 
bisacodyl capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-3011
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE K30 (UNII: U725QWY32X)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE (SOFTGELS)	Size	3mm
Flavor		Imprint Code	S71
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-3011-25	1 in 1 CARTON	12/15/2017
1		25 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	03/01/2016

Labeler - Walgreens (008965063)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
Medgel Private Ltd.		677385498	manufacture(0363-3011)