Label: DOCU- docusate sodium liquid
- NDC Code(s): 50383-771-10, 50383-771-11, 50383-771-16
- Packager: Hi-Tech Pharmacal Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
If you are a consumer or patient please visit this version.
- Active ingredient (in each teaspoon)
Docusate Sodium 50 mgClose
Stool Softener LaxativeClose
- 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.
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
- 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.
- 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 1-800-262-9010
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. 771:06 02/13Close
- Call 1-800-262-9010
- PRINCIPAL DISPLAY PANEL
(Docusate Sodium 50 mg/5 mL)
STOOL SOFTENER LAXATIVE
TAMPER EVIDENT: CAP SEALED WITH BREAKAWAY BAND AROUND BOTTLE NECK DO NOT ACCEPT IF BROKEN OR MISSING
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
NET CONTENTS ONE PINT (473 mL)Close
- INGREDIENTS AND APPEARANCE
docusate sodium liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50383-771 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg in 5 mL Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) POLOXAMER 181 (UNII: 09Y8E6164A) Product Characteristics Color PINK Score Shape Size Flavor VANILLA (natural and artificial vanilla flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50383-771-16 473 mL in 1 BOTTLE 2 NDC:50383-771-11 10 in 1 CASE 2 10 in 1 TRAY 2 NDC:50383-771-10 10 mL in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/01/1997 Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)