FDA Label for Docusate Sodium

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH 10 ML CUP)
PURPOSE
USES
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS:
OTHER INFORMATION
INACTIVE INGREDIENTS:
QUESTIONS OR COMMENTS?
DISTRIBUTED BY:
PRINCIPAL DISPLAY PANEL – TRAY LABEL
PRINCIPAL DISPLAY PANEL – CUP – 100 MG / 10 ML

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product American Health Packaging. 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.

Active Ingredient (In Each 10 Ml Cup)

Docusate sodium 100 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

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.

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: 28 mg / 10 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-vanilla flavored liquid supplied in the following:

10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-878-56

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

DO NOT USE IF SEAL IS BROKEN.

Distributed By:

American Health Packaging
Columbus, OH 43217

R12/24

Principal Display Panel – Tray Label

Case NDC 60687-878-56/Cup NDC 60687-878-42

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].

For Institutional Use Only

T0935C101224 R12/24

Principal Display Panel – Cup – 100 Mg / 10 Ml

NDC 60687- 878-42

Docusate Sodium
Liquid

Stool Softener Laxative