Dqzate Stool Softener
FDA Label NDC 53149-1001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by All Pharma Llc for the product Dqzate Stool Softener (NDC 53149-1001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warnings, active ingredient (in each softgel), purpose, uses, if pregnant or breast-feeding, keep out of reach of children., stop use and ask a doctor, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 (Labelimage)

Label (Labelimage)

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