Pedia-lax Chewable Tablets 0132-0655-01

Pedia-lax Chewable Tablets 0132-0655-01
SPL v7
SPL
SPL Set ID 975f24d8-218c-40f4-84a5-558acf34329d
Route
ORAL
Published
Effective Date 2024-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroxide Ion (400 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Red No. 40 Magnesium Stearate Maltodextrin Mannitol Sorbitol Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: Pedia;Lax Shape: round Color: pink Size: 14 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-03-01

Description

Pedia-Lax Chewable Tablets Drug Facts

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

Pedia-Lax Chewable Tablets Drug Facts

Ask
  • kidney disease

  • a magnesium-restricted diet 

  • abdominal pain, nausea or vomiting

  • a sudden change in bowel habits lasting more than 2 weeks 

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

  • already used a laxative for more than 1 week
Uses
  • For relief of occasional constipation

  • This product usually produces abowel movement in 1/2 to 6 hours
Section 42229-5

Pedia-Lax Chewable Tablets

Drug Facts

Stop Us
  • has rectal bleeding

  • does not have a bowel movement within 6 hours of using this product 

  • these symptoms maybe signs of a serious condition
Principal

Pedia-Lax®

Magnesium hydroxide

Chewable Laxative

30 chewable tablets

Directions

Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Drink a full glass (8 ounces) of liquid with each dose.

Age Starting dose Starting Dose Maximum dose per day (24 hours)
children 6 to under 12 years 3-6 tablets 6 tablets
children 2 to under 6 years 1-3 tablets 3 tablets
children under 2 years ask a doctor
Questions?

1-866-255-6960 or www.pedia-lax.com

Active Ingredient

Magnesium hydroxide 400 mg

Other Information
  • each tablet contains : 170 mg of magnesium

  • CHILD RESISTANT CAP

  • The top of the bottle sealed for safety. Do not use if foil imprinted "SEALED for YOUR PROTECTION" is broken of missing.

  • Gluten Free and Sugar Free
Inactive Ingredients

colloidal silicon dioxide, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, mannitol, sorbitol, stearic acid, sucralose

Keep Out of Reach of Children

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


Structured Label Content

Ask
  • kidney disease

  • a magnesium-restricted diet 

  • abdominal pain, nausea or vomiting

  • a sudden change in bowel habits lasting more than 2 weeks 

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

  • already used a laxative for more than 1 week
Uses
  • For relief of occasional constipation

  • This product usually produces abowel movement in 1/2 to 6 hours
Section 42229-5 (42229-5)

Pedia-Lax Chewable Tablets

Drug Facts

Purpose

Saline laxative

Stop Us (Stop us)
  • has rectal bleeding

  • does not have a bowel movement within 6 hours of using this product 

  • these symptoms maybe signs of a serious condition
Principal (PRINCIPAL)

Pedia-Lax®

Magnesium hydroxide

Chewable Laxative

30 chewable tablets

Directions

Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Drink a full glass (8 ounces) of liquid with each dose.

Age Starting dose Starting Dose Maximum dose per day (24 hours)
children 6 to under 12 years 3-6 tablets 6 tablets
children 2 to under 6 years 1-3 tablets 3 tablets
children under 2 years ask a doctor
Questions?

1-866-255-6960 or www.pedia-lax.com

Active Ingredient

Magnesium hydroxide 400 mg

Other Information (Other information)
  • each tablet contains : 170 mg of magnesium

  • CHILD RESISTANT CAP

  • The top of the bottle sealed for safety. Do not use if foil imprinted "SEALED for YOUR PROTECTION" is broken of missing.

  • Gluten Free and Sugar Free
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, mannitol, sorbitol, stearic acid, sucralose

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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