Pedia-Lax Chewable Tablets 0132-0655-01

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2024-04-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:10:52

Label at a glance#

ProductPedia-Lax
Active ingredientMAGNESIUM HYDROXIDE
Label structure10 sections

Indications and uses

For relief of occasional constipation This product usually produces abowel movement in 1/2 to 6 hours

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Pedia-Lax Chewable Tablets

Drug Facts

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 400 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

  • For relief of occasional constipation
  • This product usually produces abowel movement in 1/2 to 6 hours

Ask a doctor before using any laxative if child has

OTC - ASK DOCTOR SECTION

  • 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

Stop using this product and consult a doctor if your child

OTC - STOP USE SECTION

  • has rectal bleeding
  • does not have a bowel movement within 6 hours of using this product 
  • these symptoms maybe signs of a serious condition

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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.

AgeStarting doseStarting Dose Maximum dose per day (24 hours)
children 6 to under 12 years3-6 tablets6 tablets
children 2 to under 6 years1-3 tablets3 tablets
children under 2 yearsask a doctor

Other information

OTHER SAFETY 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 INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pedia-Lax®
Magnesium hydroxide
Chewable Laxative
30 chewable tablets

Pedia-Lax® Magnesium hydroxide Chewable Laxative 30 chewable tabletsPedia-Lax® Magnesium hydroxide Chewable Laxative 30 chewable tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
790436magnesium hydroxide 400 MG Chewable TabletPSN7
1088243Pedia-Lax Chewable 400 MG Chewable TabletPSN7
1088243magnesium hydroxide 400 MG Chewable Tablet [Pedia-Lax Chewable]SBD7
790436magnesium hydroxide 400 MG Chewable TabletSCD7
790436milk of magnesia 400 MG Chewable TabletSY7
1088243Pedia-Lax Chewable 400 MG Chewable TabletSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0655-01Pedia-Lax30 in 1 BOTTLETABLET, CHEWABLE307
0132-0655-01Pedia-Lax1 in 1 CARTONTABLET, CHEWABLE17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0655PEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]7Current NDC, Legacy NDC, 2 package rows20240410_975f24d8-218c-40f4-84a5-558acf34329d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0655-01EA - Each0132-0655476dfcc1-887f-4cb3-9f77-ec73dcf6725d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Magnesium HydroxideACTIVE INGREDIENTNBZ3QY004S4
Magnesium HydroxideACTIVE MOIETYNBZ3QY004S4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69334
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I304
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D4
MANNITOLINACTIVE INGREDIENT3OWL53L36A4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU44
SORBITOLINACTIVE INGREDIENT506T60A25R4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD44
WATERMELONINACTIVE INGREDIENT231473QB6R4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-06550132-0655-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pedia-LaxMAGNESIUM HYDROXIDEC.B. Fleet Company, Inc.975f24d8-218c-40f4-84a5-558acf34329d2024-04-11WarningsExact identifier
ndc (package): 0132-0655-01
ndc (product): 0132-0655
ndc11 (package): 00132065501
spl id: ba6860a3-95dd-4ab8-8c1d-95aa836443f1
spl set id: 975f24d8-218c-40f4-84a5-558acf34329d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.