Docqlace

Docqlace
SPL v1
SPL
SPL Set ID 35d8edf9-e296-474e-a650-977c40b5e82e
Route
ORAL
Published
Effective Date 2013-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: capsule Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-01-01

Description

Docusate sodium 100 mg

Purpose

Stool softener


Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)  
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5

Manufactured for:

QUALITEST PHARMACEUTICALS

HUNTSVILLE, AL 35811

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0677-1 100 mg 30 Capsules in a Blister Pack Reddish 0603-0150
Section 50570-1

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

doses may be taken as a single daily dose or in divided doses

adults and children 12 years and over  take 1-3 softgels daily 
children 2 to under 12 years of age  take 1 softgel daily 
children under 2 years  ask a doctor 
Other Information
  • each softgel contains: sodium 5 mg VERY LOW SODIUM  
  • store at 15°-30°C (59°-86°F)  
  • keep tightly closed

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special

Principal Display Panel

 

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.  
  • you need to use a laxative for more than 1 week
Keep Out of Reach of Children.

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

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain  
  • nausea  
  • vomiting  
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)  
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5 (42229-5)

Manufactured for:

QUALITEST PHARMACEUTICALS

HUNTSVILLE, AL 35811

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0677-1 100 mg 30 Capsules in a Blister Pack Reddish 0603-0150
Section 50570-1 (50570-1)

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Stool softener

Directions

doses may be taken as a single daily dose or in divided doses

adults and children 12 years and over  take 1-3 softgels daily 
children 2 to under 12 years of age  take 1 softgel daily 
children under 2 years  ask a doctor 
Other Information (Other information)
  • each softgel contains: sodium 5 mg VERY LOW SODIUM  
  • store at 15°-30°C (59°-86°F)  
  • keep tightly closed

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients (Inactive ingredients)

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

 

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.  
  • you need to use a laxative for more than 1 week
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain  
  • nausea  
  • vomiting  
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)