Gentle Laxative Womens: Package Insert and Label Information

GENTLE LAXATIVE WOMENS- bisacodyl tablet, delayed release
Harmon Store Inc.

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.

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

• for relief of occasional constipation (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

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

When using this product

• do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk

• you may have stomach discomfort, faintness and cramps

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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 (1-800-222-1222) right away.

Directions

• take with a glass of water

adults and children 12years and over	take 1 to 3 tablets in asingle daily dose
children 6 to under 12years	take 1 tablet in a singledaily dose
children under 6 years	ask a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• avoid excessive humidity
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

CORE VALUES™

Women’s
Gentle Laxative
Bisacodyl USP, 5 mg
Stimulant Laxative

Gentle, dependable overnight relief

30 coated tablets

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844 ORG011967601

Distributed by:
Liberty Procurement, Inc.,
650 Liberty Ave., Union,
NJ 07083 U.S.A.
Satisfaction Guaranteed
Or Your Money Back
Visit us at www.facevalues.com

Core Values 44-676A

GENTLE LAXATIVE WOMENS bisacodyl tablet, delayed release

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-676 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 SILICON DIOXIDE STARCH, CORN FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED ANHYDROUS LACTOSE MAGNESIUM STEARATE METHACRYLIC ACID MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SHELLAC DIMETHICONE WATER SODIUM BICARBONATE SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE

Product Characteristics Color pink Score no score Shape ROUND Size 8mm Flavor Imprint Code B Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63940-676-01 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (63940-676-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/16/2015

Labeler — Harmon Store Inc. (804085293)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	pack (63940-676)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	pack (63940-676)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867894	manufacture (63940-676)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		868734088	pack (63940-676)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	pack (63940-676)

Revised: 07/2022 Harmon Store Inc.