- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredient (in each teaspoon)
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
FULL PRESCRIBING INFORMATION
Active ingredient (in each teaspoon)
Docusate Sodium 50 mg
Stool Softener Laxative
- relieves occasional constipation
- generally produces bowel movement in 12-72 hours
Do not use
- if you are presently taking mineral oil
- when abdominal pain, nausea, or vomiting are present
- for longer than one week
Ask a doctor before use if you have
noticed a sudden change in bowel habits that lasts over two weeks.
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.
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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- 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.
D&C Red #33, methylparaben, planifoline, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.
Questions or comments?
- Call 1-800-262-9010
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.
REV. 771:04 07/10
PRINCIPAL DISPLAY PANEL
(Docusate Sodium 50 mg/5 mL)
NET CONTENTS ONE PINT (473 mL)
STOOL SOFTENER LAXATIVE
TAMPER EVIDENT: FOR YOUR PROTECTION, THIS BOTTLE HAS A SAFETY SEAL AROUND THE NECK OR UNDER THE CAP.
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Additional bar code labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
Docusate Sodium LIQUID