Children’s Oral Saline Laxative Chewable Tablets

Children’s Oral Saline Laxative Chewable Tablets

Drug Labeling and Warnings

Drug Details

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CHILDRENS ORAL SALINE LAXATIVE- magnesium hydroxide tablet, chewable 
WAL-MART STORES,INC.,

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Children’s Oral Saline Laxative Chewable Tablets

Active Ingredient

Magnesium hydroxide 400 mg

Purpose

Saline laxative

Uses

  • ▪ for relief of occasional constipation
  • ▪ this product usually produces bowel movement in 1/2 to 6 hours

Warnings

Ask a doctor before using any laxative if child has

  • ▪ kidney disease
  • ▪ a magnesium-restricted diet
  • ▪ abdominal pain, nausea or vomiting
  • ▪ a sudden change in bowel habits lasting more than 2 weeks
  • ▪ constipation continues after 1 week of use, contact your child's doctor
  • ▪ already used a laxative for more than 1 week

Stop use and consult a doctor if your child has

  • has rectal bleeding
  • does not have a bowel movement within 6 hours of taking this product

These symptoms may indicate a serious condition.

Keep out of reach of children

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

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

Maximum dose per day

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

Other information

  • each tablet contains: magnesium 170 mg
  • store at room temperature

Inactive ingredients

dextrose, FD&C Red 40 aluminum lake, magnesium stearate, maltodextrin, natural & artificial flavor, sorbitol, starch, sucralose.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Pedia-Lax®

NDC# 49035-307-30

Children’s Oral Saline Laxative

  • Treats constipation
  • Relief in ½ to 6 hours
  • Safe and gentle for kids

For ages 2-11 years

Watermelon Flavor

Naturally and Artificially Flavored

30 Chewable Tablets

IMPORTANT: Keep this carton for future reference on full labeling.

Poop Should Just Happen.

These tablets are designed for quick, yet gentle relief in 30 minutes to 6 hours. Tasty watermelon-flavored chewable tablets are appropriately dosed for children and allow relief without the painful cramping sometimes associated with stimulant laxatives.

Distributed by:

Wal-Mart Stores, Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by C.B. Fleet Company Inc., the distributor of Pedia-Lax®.

Childrens Oral Saline Laxative 30 Chewable Tablets
CHILDRENS ORAL SALINE LAXATIVE 
magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49035-307
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATERMELON (UNII: 231473QB6R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SORBITOL (UNII: 506T60A25R)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPINK (light) Score2 pieces
ShapeROUNDSize14mm
FlavorWATERMELONImprint Code RP129
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49035-307-301 in 1 CARTON03/10/2020
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/10/2020
Labeler - WAL-MART STORES,INC., (051957769)

Revised: 3/2020
 
WAL-MART STORES,INC.,


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