CVS HEALTH CHILDRENS SALINE LAXATIVE- magnesium hydroxide tablet, chewable

CVS Health Childrens by

Drug Labeling and Warnings

CVS Health Childrens by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY,INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• ▪ 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 and artificial flavor, sorbitol, starch, sucralose.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

CVS Health™

Compare to the active ingredientPedia-Lax®*

NDC# 69842-912-30

Children’s

Saline Laxative

• Digestive relief without cramping
• Stimulant-free
• Works in ½ to 6 hours

For ages 2-11 years

Watermelon Flavor

Naturally and Artificially Flavor

30 CHEWABLE TABLETS

CVS Health™ Children’s Saline Laxative is a mild and effective laxative designed to be gentle on your little one’s digestive system with no cramping and no stimulants. The chewable tablets make it easy to take.

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

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com 1-800-SHOP CVS

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INGREDIENTS AND APPEARANCE

CVS HEALTH CHILDRENS  SALINE LAXATIVE
magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-912
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor	WATERMELON (naturally and artificially)	Imprint Code	RP129
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-912-30	1 in 1 CARTON	05/16/2019
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/16/2019

Labeler - CVS PHARMACY,INC. (062312574)