Docusate Calcium

Docusate Calcium
SPL v6
SPL
SPL Set ID 871cdcd5-bf8e-4c70-8505-c81cf1c4fe33
Route
ORAL
Published
Effective Date 2021-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (240 mg)
Inactive Ingredients
Gelatin Glycerin Sorbitol Water Fd&c Blue No. 1 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Imprint: SCU Shape: oval Color: red Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-13

Description

Docusate Calcium 240 mg

Purpose

Stool Softener


Medication Information

Purpose

Stool Softener

Description

Docusate Calcium 240 mg

Uses
  • For the relief of occasional constipation.
  • This product generally produces a bowel movement within 12 to 72 hours.
Directions

Adults and Children over 12 years of age

Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Active Ingredient

Docusate Calcium 240 mg

Other Information
  • Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF).
  • Do not use if either seal is broken or missing.
Inactive Ingredients

FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Sorbitol Special.

Warnings: Do Not Use
  • If you are currently taking mineral oil, unless directed by a doctor.
  • When abdominal pain, nausea or vomiting are present.
  • For longer than one week unless directed by a doctor.
Questions Or Comments

Distributed by AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

Questions or Concerns? www.mygnp.com

Questions? 800-321-7178

MADE IN ROMANIA

REV. 2/21 DOCC110GN

Ask A Doctor Before Use

■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel habits that lasts over 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 healthcare professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package/label Principal Display Panel


Structured Label Content

Uses
  • For the relief of occasional constipation.
  • This product generally produces a bowel movement within 12 to 72 hours.
Purpose

Stool Softener

Directions

Adults and Children over 12 years of age

Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Active Ingredient (Active ingredient)

Docusate Calcium 240 mg

Other Information
  • Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF).
  • Do not use if either seal is broken or missing.
Inactive Ingredients

FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Sorbitol Special.

Warnings: Do Not Use (Warnings: Do not use)
  • If you are currently taking mineral oil, unless directed by a doctor.
  • When abdominal pain, nausea or vomiting are present.
  • For longer than one week unless directed by a doctor.
Questions Or Comments (Questions or Comments)

Distributed by AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

Questions or Concerns? www.mygnp.com

Questions? 800-321-7178

MADE IN ROMANIA

REV. 2/21 DOCC110GN

Ask A Doctor Before Use (Ask a Doctor Before Use)

■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel habits that lasts over 2 weeks

Stop Use and Ask A Doctor If (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 (If Pregnant or Breast Feeding)

Ask a healthcare professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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