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

Purpose

Stool Softener

Description

Docusate Sodium 100mg


Medication Information

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.

Uses

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

Purpose

Stool Softener

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.

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

Description

Docusate Sodium 100mg

Active Ingredient

Docusate Sodium 100mg

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

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.

Uses

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

Purpose

Stool Softener

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.

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

Active Ingredient (Active ingredient)

Docusate Sodium 100mg

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

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