FDA Label for Docusate Sodium

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT (IN EACH 5 ML)
PURPOSE
USES
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
STOP USE AND ASK A DOCTOR IF
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL - 10 ML CUP TRAY LABEL

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

R06/22

Distributed by:

MAJOR ^® PHARMACEUTICALS

Indianapolis, IN 46268

Active Ingredient (In Each 5 Ml)

Docusate sodium 50 mg

Purpose

Stool softener

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

Do Not Use

if you are presently taking mineral oil, unless told to do so by a doctor

Ask A Doctor Before Use If You Have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

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
rash occurs

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Directions

Dose once daily
take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.

adults and children 12 years and older	5 to 20 mL (1 to 4 teaspoonfuls)
children 6 to under 12 years of age	5 to 10 mL (1 to 2 teaspoonfuls)
children 3 to under 6 years of age	2.5 to 5 mL (1/2 to 1 teaspoonful)
children under 3 years	ask a doctor

Other Information

• Sodium content: 14 mg/ 5 mL
• Store at controlled room temperature, 20° to 25°C (68° to 77°F)
• Protect from freezing
• Protect from light
• Clear pink to purple-pink colored, cherry flavored liquid supplied in the following:

NDC 0904-7279-66: 10 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients

artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.

Questions Or Comments?

Call 1-800-845-8210

Principal Display Panel - 10 Ml Cup Tray Label

NDC 0904-7279-66

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Delivers 10 mL

See insert

For Institutional Use Only