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NDC 00132-0655-01 Pedia-Lax 400 mg/1 Details
Pedia-Lax 400 mg/1
Pedia-Lax is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by C.B. Fleet Company, Inc.. The primary component is MAGNESIUM HYDROXIDE.
MedlinePlus Drug Summary
Magnesium hydroxide is used to treat occasional constipation in children and adults on a short-term basis. Magnesium hydroxide is in a class of medications called saline laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.
Related Packages: 00132-0655-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Magnesium Hydroxide
Product Information
| NDC | 00132-0655 |
|---|---|
| Product ID | 0132-0655_efb807d6-fe33-4e99-8b0b-8bd9e2f09f7d |
| Associated GPIs | 46100010100530 |
| GCN Sequence Number | 065999 |
| GCN Sequence Number Description | magnesium hydroxide TAB CHEW 400MG(170) ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 28165 |
| HICL Sequence Number | 001329 |
| HICL Sequence Number Description | MAGNESIUM HYDROXIDE |
| Brand/Generic | Brand |
| Proprietary Name | Pedia-Lax |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Magnesium hydroxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/1 |
| Substance Name | MAGNESIUM HYDROXIDE |
| Labeler Name | C.B. Fleet Company, Inc. |
| Pharmaceutical Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00132-0655-01 (00132065501)
| NDC Package Code | 0132-0655-01 |
|---|---|
| Billing NDC | 00132065501 |
| Package | 1 BOTTLE in 1 CARTON (0132-0655-01) / 30 TABLET, CHEWABLE in 1 BOTTLE |
| Marketing Start Date | 2008-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 975f24d8-218c-40f4-84a5-558acf34329d Details
Uses
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
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 |
Other information
Inactive ingredients
INGREDIENTS AND APPEARANCE
| PEDIA-LAX
magnesium hydroxide tablet, chewable |
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| Labeler - C.B. Fleet Company, Inc. (003119054) |