GENTLE RELIEF STOOL SOFTNER- gentle relief stool softnet capsule, gelatin coated

Gentle Relief Stool Softner by

Drug Labeling and Warnings

Gentle Relief Stool Softner by is a Otc medication manufactured, distributed, or labeled by Healthlife of USA, Softech Pharma Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Gentle Relief Stool Softner

Purpose

Stool Softner

Active Ingredient (in each softgel)

Docusate sodium 100mg

Uses

• For 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 presently taking mineral oil, unless directed by a doctor
• when abdominal pain, nausea, or vomiting are present
• For longer than 1 week, unless directed by a doctor

Ask a doctor before use if you have

Noticed a sudden change in bowel habits that continues 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

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children

Overdose warning: In case of overdosage, get medical help or contact a Poison Control Center right away.

Directions

• Take with a glass of water
• Adults and children 12 years of age and over: Take 1 to 3 softgels daily. This dose may be taken as single daily dose or in divided doses
• Children 2 to under 12 years of age: Take 1 softgel daily
• Children under 2 years of age: Consult a physician

Other Information

Each softgel contains sodium 6 mg
Store at controlled room temperature 15°-30°C (59°-86°F)
Read all product information before using
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

• FD&C Red # 40
• FD&C Yellow # 6
• Gelatin
• Glycerin
• Polyethylene glycol 400
• Propylene glycol
• Purified water
• Sorbitol solution
• Titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Gentle ReliefStool SoftnerDocusate Sodium 100mgGentle and Easy Relief of Constipation24 Softgels Distributed by:Healthlife of USA LLCRahwayNJ 07065www.healthlifeofusa.com

Compare to Dulcolax® Stool Softner active ingredients

INGREDIENTS AND APPEARANCE

GENTLE RELIEF STOOL SOFTNER 
gentle relief stool softnet capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-124
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-124-24	1 in 1 CARTON	05/31/2017
1		24 in 1 BOTTLE; 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	05/31/2017

Labeler - Healthlife of USA (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Healthlife of USA		079656178	repack(69517-124)

Establishment
Name	Address	ID/FEI	Business Operations
Softech Pharma Pvt. Ltd.		677111277	manufacture(69517-124) , pack(69517-124)