Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 7fdc4368-4888-4792-86d3-c8a828e4fff2
Route
ORAL
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg)
Inactive Ingredients
D&c Red No. 33 Methylparaben Polyethylene Glycol 400 Propylene Glycol Propylparaben Sodium Benzoate Sodium Citrate, Unspecified Form Water Poloxamer 181

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1997-08-01

Description

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative


Medication Information

Purpose

Stool Softener Laxative

Description

Docusate Sodium 50 mg

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 12-72
Directions
  • may be taken once daily or in divided doses
  • give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation

adults and children over 12

1 to 7 teaspoons

children 2 to under 12

1 to 3 teaspoons

children under 2

ask a doctor

Do Not Use
  • if you are presently taking mineral oil
  • when abdominal pain, nausea, or vomiting are present
  • for longer than one week
Active Ingredient

Docusate Sodium 50 mg

Other Information
  • each teaspoon contains: sodium 5 mg
  • shake well before using
  • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP
  • store in an upright position
Inactive Ingredients

D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

Questions Or Comments?
  • Call 1-800-932-5676

Mon - Thurs. 9:00 am - 4:30 pm EST, Fri. 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product

These may indicate a serious condition.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have

noticed a sudden change in bowel habits that lasts over two weeks.

Package/label Principal Display Panel

NDC 50383-771-16

DOCU LIQUID

(Docusate Sodium 50 mg/5 mL)

STOOL SOFTENER LAXATIVE

TAMPER EVIDENT: FOR YOUR PROTECTION THE CHILD RESISTANT CAP HAS A PRINTED SAFETY SEAL AROUND THE NECK. DO NOT ACCEPT IF BROKEN OR MISSING.

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

NET CONTENTS ONE PINT (473 mL)

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.


Structured Label Content

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 12-72
Purpose

Stool Softener Laxative

Directions
  • may be taken once daily or in divided doses
  • give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation

adults and children over 12

1 to 7 teaspoons

children 2 to under 12

1 to 3 teaspoons

children under 2

ask a doctor

Do Not Use
  • if you are presently taking mineral oil
  • when abdominal pain, nausea, or vomiting are present
  • for longer than one week
Active Ingredient (Active ingredient)

Docusate Sodium 50 mg

Other Information (Other information)
  • each teaspoon contains: sodium 5 mg
  • shake well before using
  • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP
  • store in an upright position
Inactive Ingredients

D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

Questions Or Comments? (Questions or comments?)
  • Call 1-800-932-5676

Mon - Thurs. 9:00 am - 4:30 pm EST, Fri. 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product

These may indicate a serious condition.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

noticed a sudden change in bowel habits that lasts over two weeks.

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

NDC 50383-771-16

DOCU LIQUID

(Docusate Sodium 50 mg/5 mL)

STOOL SOFTENER LAXATIVE

TAMPER EVIDENT: FOR YOUR PROTECTION THE CHILD RESISTANT CAP HAS A PRINTED SAFETY SEAL AROUND THE NECK. DO NOT ACCEPT IF BROKEN OR MISSING.

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

NET CONTENTS ONE PINT (473 mL)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)