EXTRA STRENGTH STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled

EXTRA STRENGTH STOOL SOFTENER LAXATIVE by

Drug Labeling and Warnings

EXTRA STRENGTH STOOL SOFTENER LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Aidapak Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each softgel)

Docusate Sodium 250 mg

PURPOSE

Purpose

Stool Softener

INDICATIONS & USAGE

Uses:

for the prevention of dry, hard stools

for relief of occasional constipation

this product generally produces a bowel movement within 12 to 72 hours.

WARNINGS

Do not use

if you are currently taking mineral oil, unless directed by a doctor

when abdominal pain, nausea, or

vomiting are present

for more than 1 week, unless directed by a doctor.

ASK DOCTOR

Ask a doctor before use if:

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if:

you have rectal bleeding

you fail to have a bowel movement after use. These could be signs of a serious condition.

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 Poison Control Center right away.

INFORMATION FOR PATIENTS

Directions:

Adults and children 12 years of age and over:

take 1 softgel daily or as directed by a doctor.

Children under 12 years of age: take as directed by doctor.

Other Information:

each softgel contains: sodium 15 mg.

Store between 15-30 C (59-86 F)

INACTIVE INGREDIENT

edible white ink, FD&C red 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

PRINCIPAL DISPLAY PANEL

DOSAGE & ADMINISTRATION

KEEP OUT OF REACH OF CHILDREN

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52327-011(NDC: 0536-3757)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg  in 250 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	P20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52327-011-11	100 in 1 BLISTER PACK	10/20/2014
1	NDC: 52327-011-10	1 mg in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/20/2014

Labeler - Aidapak Services, LLC (831612457)

Registrant - Aidapak Services, LLC (831612457)

Establishment
Name	Address	ID/FEI	Business Operations
Aidapak Services, LLC		831612457	relabel(52327-011)