DQZATE STOOL SOFTENER- docusate sodium capsule, gelatin coated 
All Pharma LLC

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.

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DQZATE Stool Softner

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

Label

DQZATE STOOL SOFTENER 
docusate sodium capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53149-1001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapecapsuleSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53149-1001-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/01/2019
Labeler - All Pharma LLC (078572520)
Establishment
NameAddressID/FEIBusiness Operations
All Pharma LLC078572520label(53149-1001)

Revised: 10/2020
Document Id: cf914d58-4aa1-405d-a521-70fa3eb54dcb
Set id: b1dcbfb8-55fe-4882-9021-6120f3100617
Version: 1
Effective Time: 20201016
 
All Pharma LLC