Pedia-lax Docusate Stool Softener_0132-0113

Pedia-lax Docusate Stool Softener_0132-0113
SPL v1
SPL
SPL Set ID 0e908bea-ebab-44e7-919c-90002e6f5d42
Route
ORAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg)
Inactive Ingredients
Citric Acid Monohydrate Edetate Disodium Methylparaben Polyethylene Glycol, Unspecified Povidone Propylene Glycol Propylparaben Sodium Citrate Sorbitol Sucralose Water Xanthan Gum Xylitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-28

Description

Drug Facts

Purpose

Stool softener


Medication Information

Purpose

Stool softener

Description

Drug Facts

Uses

for prevention of dry, hard stools

for relief of occasional constipation

this product usually produces a bowel movement in 12 to 72 hours

Section 42229-5

Drug Facts

Warnings

Drug Interaction Precaution: Do not give this product to your child if your   child is presently taking mineral oil, unless directed by a doctor.

Directions

do not give more than 45 mL in any 24 hour period

use only with enclosed dosing cup

find right dose on chart below

mL = milliliter

Age Dose

Children 2 to under 12

years

15 mL to 45 mL; do not take more than 45 mL in 24

hours

Children under 2 years ask a doctor

Doses can be diluted in a suitable beverage to prevent throat irritation and   to help mask the naturally tart flavor of the active ingredient (see side panel   for info).

Questions?

1-866-255-6960 or www.pedia-lax.com

Other Information

each 15 mL contains: sodium 13 mg  the top of the bottle is sealed with foil for your safety. Do not use if foil imprinted "sealed for your protection" is broken or missing.

gluten free

Active Ingredients

(in each 15 mL)

Docusate Sodium 50 mg

Inactive Ingredients

citric acid, edetate disodium, flavor, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, sodium citrate, sorbitol, sucralose, water, xanthan gum, xylitol

Principal Display Panel

Pedia-Lax

Docusate sodium

Liquid Stool Softener

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL

Pedia•Lax

Docusate sodium

Liquid Stool Softener

4 fl oz (118 mL)

Ask A Doctor Before Using

any laxative if your child has

a sudden change in bowel habits lasting more than 2 weeks

already used a laxative for more than 1 week

If constipation continues after 1 week of use, contact your child's doctor

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Using This Product and Consult A Doctor If Your Child Has

rectal bleeding

no bowel movement within 72 hours of using this product

These symptoms may be signs of a serious condition.


Structured Label Content

Uses

for prevention of dry, hard stools

for relief of occasional constipation

this product usually produces a bowel movement in 12 to 72 hours

Section 42229-5 (42229-5)

Drug Facts

Purpose

Stool softener

Warnings

Drug Interaction Precaution: Do not give this product to your child if your   child is presently taking mineral oil, unless directed by a doctor.

Directions

do not give more than 45 mL in any 24 hour period

use only with enclosed dosing cup

find right dose on chart below

mL = milliliter

Age Dose

Children 2 to under 12

years

15 mL to 45 mL; do not take more than 45 mL in 24

hours

Children under 2 years ask a doctor

Doses can be diluted in a suitable beverage to prevent throat irritation and   to help mask the naturally tart flavor of the active ingredient (see side panel   for info).

Questions?

1-866-255-6960 or www.pedia-lax.com

Other Information (Other information)

each 15 mL contains: sodium 13 mg  the top of the bottle is sealed with foil for your safety. Do not use if foil imprinted "sealed for your protection" is broken or missing.

gluten free

Active Ingredients

(in each 15 mL)

Docusate Sodium 50 mg

Inactive Ingredients

citric acid, edetate disodium, flavor, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, sodium citrate, sorbitol, sucralose, water, xanthan gum, xylitol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Pedia-Lax

Docusate sodium

Liquid Stool Softener

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL

Pedia•Lax

Docusate sodium

Liquid Stool Softener

4 fl oz (118 mL)

Ask A Doctor Before Using (Ask a doctor before using)

any laxative if your child has

a sudden change in bowel habits lasting more than 2 weeks

already used a laxative for more than 1 week

If constipation continues after 1 week of use, contact your child's doctor

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 (1-800-222-1222) right away.

Stop Using This Product and Consult A Doctor If Your Child Has (Stop using this product and consult a doctor if your child has)

rectal bleeding

no bowel movement within 72 hours of using this product

These symptoms may be signs of a serious condition.


Advanced Ingredient Data


Raw Label Data

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