FDA Label for Stool Softener

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that lasts longer than 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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

Otc - 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.

Directions

• Take only by mouth.

Adults and children 12 years of age and older	1 to 3 capsules daily. May be taken as a single daily dose or in divided doses.
Children 2 to under 12 years of age	1 capsule daily
Children under 2 years	Ask a doctor

Other Information

• each softgel contains: sodium 7 mg. very low sodium

• store at 59°-77°F (15°-25°C)

• keep tightly closed

• product of Romania

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

Inactive Ingredients

gelatin, glycerin, PEG, purified water, sorbitol special. Contains less that 1% of D&C red #33, edible ink, FD&C red #40, FD&C yellow #6 (sunset yellow), titanium dioxide

Package Label