DQZATE STOOL SOFTENER- docusate sodium capsule, gelatin coated

DQZATE STOOL SOFTENER by

Drug Labeling and Warnings

DQZATE STOOL SOFTENER by is a Otc medication manufactured, distributed, or labeled by All Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

Do Not use if you are presently taking mineral oils unless told to do so by a doctor.

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

relief of occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

If pregnant or breast-feeding

ask a doctor before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor

If you have rectal bleeding

If you fail to have bowel movement after use of a laxative

If you need to use a stool softner laxative for more than a week

Directions

Adults and children 12 years and over:Take 1-3 Capsules once daily or in divided doses.

Children 6 years to under 12:Take one capsule once a day.

Children under 6 years: Ask your Doctor.

Other information

each softgel contains: sodium 7 mg

keep tightlyl closed

store at room temperature 15°-30°C (59°-86°F) in a dry place

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, sorbitol,purified water

DQZate

Label

INGREDIENTS AND APPEARANCE

DQZATE STOOL SOFTENER 
docusate sodium capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53149-1001
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 RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score	no score
Shape	capsule	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53149-1001-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/01/2019

Labeler - All Pharma LLC (078572520)

Establishment
Name	Address	ID/FEI	Business Operations
All Pharma LLC		078572520	label(53149-1001)