PUBLIX WOMEN LAXATIVE- bisacodyl tablet

Publix Women by

Drug Labeling and Warnings

Publix Women by is a Otc medication manufactured, distributed, or labeled by PUBLIX SUPER MARKETS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bisacodyl, USP 5 mg

Purpose

Laxative

Use

• ▪ for relief of occasional constipation (irregularity)
• ▪ this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

for children under 6 years of age.

Ask a doctor before use if you have

• ▪ abdominal 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
• ▪ do not use within 1 hour after taking an antacid or milk
• ▪ abdominal discomfort, faintness and cramps may occur

Stop use and ask a doctor if

• ▪ you need to use a laxative for more than 1 week
• ▪ rectal bleeding or failure to have a bowel movement after use of laxative. These could be signs of a serious condition.

If pregnancy 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 at (1-800-222-1222).

Directions

• ▪ each laxative works differently. Adults and children over 12 may need fewer tablets to get the same effect as more tablets of another brand.
• ▪ start with one tablet and take with water. If one tablet does not produce the desired results, then try two or three tablets daily.
• ▪ do not take more than three tablets daily

• adults and children 12 years of age and older:

  take 1 to 3 tablets in a single dose once daily

• children 6 to under 12 year of age:

  take 1 tablets once daily

• children under 6 years of age:

  ask a doctor

Other information

• ▪ each tablet contains: calcium 20 mg
• ▪ store at room temperature
• ▪ keep this carton for future reference on full labeling.

Inactive ingredients

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C Red No. 7, 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.

Questions or comments?

1-888-267-3037

Principal Display Panel

NDC# 41415-121-30

*Compare to the Correctol® active ingredient

WOMEN’S laxative

BISACODYL, USP 5 mg

STIMULANT LAXATIVE

• For gentle, overnight relief from irregularity

30 TABLETS

*This product is not manufactured or distributed by Schering Plough Healthcare Products, Inc., owner of the registered trademark Correctol®.

TAMPER EVIDENT: DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN.

IMPORTANT: Keep this carton for future reference on full labeling.

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

1-888-267-3037 publix.com

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUE MONEY BACK

Product Label

INGREDIENTS AND APPEARANCE

PUBLIX WOMEN  LAXATIVE
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41415-121
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
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
RAW SUGAR (UNII: 8M707QY5GH)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	RP121
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41415-121-30	2 in 1 CARTON	05/22/2019
1		15 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	05/22/2019

Labeler - PUBLIX SUPER MARKETS, INC (006922009)