Kro 406

Kro 406
SPL v4
SPL
SPL Set ID a1afaa71-7e8c-5a49-e053-2a95a90a4db0
Route
ORAL
Published
Effective Date 2013-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Titanium Dioxide D&c Red No. 33 Polyethylene Glycol 400 Fd&c Red No. 40 Gelatin Glycerin Sorbitol Water Fd&c Yellow No. 6 Mannitol

Identifiers & Packaging

Pill Appearance
Imprint: SCU2 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01

Description

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative


Medication Information

Purpose

Stool Softener Laxative

Description

Docusate Sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 50565-1

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

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.

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

Package Label

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

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 50565-1 (50565-1)

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

Purpose

Stool Softener Laxative

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.

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

Package Label

Other Information (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 (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

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

Docusate Sodium 100 mg


Advanced Ingredient Data


Raw Label Data

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