Docusate Sodium Drug Facts

Docusate Sodium Drug Facts
SPL v1
SPL
SPL Set ID 7e23b026-fee4-436a-b378-33d31d6d8b40
Route
ORAL
Published
Effective Date 2011-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Red No. 33 D&c Yellow No. 10 Ethyl Vanillin Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Mannitol Methylparaben Polyethylene Glycol Propylene Glycol Propylparaben Sorbitol Water

Identifiers & Packaging

Pill Appearance
Imprint: A92 Shape: oval Color: red Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2007-01-01

Description

Docusate Sodium 100mg

Purpose

Stool Softener


Medication Information

Purpose

Stool Softener

Description

Docusate Sodium 100mg

Uses

Prevents / relieves dry hard stool. Results usually occur 1 to 3 days after the first dose.

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you have abdominal pain, nausea, or vomiting; have noticed a sudden change in bowel habits that lasts over 2 weeks,; are taking mineral oil.

Stop use and ask a doctor if you have no bowel movement within 3 days; you have rectal bleeding. These could be signs of a serious condition.

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

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Directions

Adults and children 12 years and older: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor.

Children under 12: consult a doctor.

Do not exceed recommended dose.

Active Ingredient

Docusate Sodium 100mg

Other Information

Each softgel contains sodium 5mg.

Product from Canada or USA

Store at room temperature, 15°C-30°C (59°F-86°F)

Inactive Ingredients

may contain cirtic acid, D&C red no. 33, D&C yellow no. 10, ethyl vanillin, FD&C blue no. 1, FD&C re no. 40 FD&C yellow no. 6, gelatin, glycerin, edible ink, mannitol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, sorbitol, water.

Distributed by:

Geri-Care Pharmaceuticals Corp.

Brooklyn, NY 11204

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control center right way.

Package/label Principal Display Panel


Structured Label Content

Uses

Prevents / relieves dry hard stool. Results usually occur 1 to 3 days after the first dose.

Purpose

Stool Softener

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you have abdominal pain, nausea, or vomiting; have noticed a sudden change in bowel habits that lasts over 2 weeks,; are taking mineral oil.

Stop use and ask a doctor if you have no bowel movement within 3 days; you have rectal bleeding. These could be signs of a serious condition.

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

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Directions

Adults and children 12 years and older: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor.

Children under 12: consult a doctor.

Do not exceed recommended dose.

Active Ingredient (Active ingredient)

Docusate Sodium 100mg

Other Information

Each softgel contains sodium 5mg.

Product from Canada or USA

Store at room temperature, 15°C-30°C (59°F-86°F)

Inactive Ingredients (Inactive ingredients)

may contain cirtic acid, D&C red no. 33, D&C yellow no. 10, ethyl vanillin, FD&C blue no. 1, FD&C re no. 40 FD&C yellow no. 6, gelatin, glycerin, edible ink, mannitol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, sorbitol, water.

Distributed by:

Geri-Care Pharmaceuticals Corp.

Brooklyn, NY 11204

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control center right way.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)