Label: PEDIA-LAX- magnesium hydroxide tablet, chewable
- NDC Code(s): 0132-0655-01
- Packager: C.B. Fleet Company, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 30, 2017
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- Active Ingredient
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
- rectal bleeding
- no bowel movement within 6 hours of using this product
These symptoms may indicate a serious condition.
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 Maxiumm 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
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
magnesium hydroxide tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0655 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MANNITOL (UNII: 3OWL53L36A) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color pink Score 2 pieces Shape ROUND Size 14mm Flavor WATERMELON Imprint Code Pedia;Lax Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0655-01 1 in 1 CARTON 03/01/2008 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 03/01/2008 Labeler - C.B. Fleet Company, Inc. (003119054)