Laxative

Laxative
SPL v6
SPL
SPL Set ID 39b4caf7-a278-40d4-831a-1f74c871e261
Route
ORAL
Published
Effective Date 2021-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Paraffin Lecithin, Soybean Synthetic Beeswax Silicon Dioxide Carboxymethylcellulose Sodium Titanium Dioxide Gelatin Glycerin Noncrystallizing Sorbitol Solution Povidone K30 Fd&c Yellow No. 6 D&c Red No. 33 Fd&c Red No. 40 Water

Identifiers & Packaging

Pill Appearance
Imprint: 584 Shape: oval Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-27

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Laxative


Medication Information

Purpose

Stool softener

Laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Label

Carton

Section 42229-5

Distributed by:

RITE AID

30 Hunter Lane, Camp Hill, PA 17011



www.riteaid.com



Made in India

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition • you need to use a stool softener

laxative for more than 1 week

Section 50568-5

Ask a doctor or pharmacist before use if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Section 50569-3

Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that continues over a period of 2 weeks

Section 50570-1

Do not use • if you are now taking mineral oil, unless directed by a doctor • laxative products for longer than 1 week, unless directed by a doctor

Section 53414-9

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

Directions

take preferably at bedtime or as directed by a doctor

Age  Starting Dosage  Maximum Dosage
adults & children 12 years of age & over  2 tablets once a day  4 tablets twice a day 
children 6 to under 12 years of age  1 tablet once a day  2 tablets twice a day 
children 2 to under 6 years  ½ tablet once a day  1 tablet twice a day 
children under 2 years  ask a doctor  ask a doctor 

Drug Facts

Other Information

• each tablet contains: calcium 2 mg and sodium 6 mg

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)

Inactive Ingredients

Light liquid paraffin, Soya lecithin, Beeswax, Colloidal silicon dioxide (aerosol), Sodium Carboxymethyl Cellulose, titanium dioxide, Gelatin, Glycerin, Sorbitol sorbitan, Povidone, FD&C Yellow-6, FD&C Red-33, spl, Purified water

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Softgel)

Docusate sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

Uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Label

Carton

Section 42229-5 (42229-5)

Distributed by:

RITE AID

30 Hunter Lane, Camp Hill, PA 17011



www.riteaid.com



Made in India

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. (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask a doctor if • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition • you need to use a stool softener

laxative for more than 1 week

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that continues over a period of 2 weeks

Section 50570-1 (50570-1)

Do not use • if you are now taking mineral oil, unless directed by a doctor • laxative products for longer than 1 week, unless directed by a doctor

Section 53414-9 (53414-9)

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

Purpose

Stool softener

Laxative

Directions

take preferably at bedtime or as directed by a doctor

Age  Starting Dosage  Maximum Dosage
adults & children 12 years of age & over  2 tablets once a day  4 tablets twice a day 
children 6 to under 12 years of age  1 tablet once a day  2 tablets twice a day 
children 2 to under 6 years  ½ tablet once a day  1 tablet twice a day 
children under 2 years  ask a doctor  ask a doctor 

Drug Facts

Other Information (Other information)

• each tablet contains: calcium 2 mg and sodium 6 mg

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)

Inactive Ingredients (Inactive ingredients)

Light liquid paraffin, Soya lecithin, Beeswax, Colloidal silicon dioxide (aerosol), Sodium Carboxymethyl Cellulose, titanium dioxide, Gelatin, Glycerin, Sorbitol sorbitan, Povidone, FD&C Yellow-6, FD&C Red-33, spl, Purified water

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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

Docusate sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)