Aluminum Hydroxide
FDA Label NDC 24451-091

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llc Federal Solutions for the product Aluminum Hydroxide (NDC 24451-091). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each 5 mL teaspoonful)
Aluminum hydroxide 320 mg

Otc - Purpose

Purpose
Antacid

Indications & Usage

Uses
For the relief of

  • heartburn
  • acid indigestion
  • sour stomach

Warnings

Warnings

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.

Otc - When Using

When using this product you may get constipated

Otc - Stop Use

Stop use and ask a doctor if symptoms last more than 2 weeks

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children.

Dosage & Administration

Directions

  • shake well before using
  • do not take more than 12 teaspoonfuls in 24 hours
  • do not use the maximum dosage for more than 2 weeks
  • dosage: 2 teaspoonfuls 5-6 times daily after meals and at bedtime followed by a sip of water if needed

Other Safety Information

Other information

  • store at room temperature
  • protect from freezing
  • keep tightly closed

Inactive Ingredient

Inactive ingredients
benzyl alcohol, butylparaben, flavor, glycerin, hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol solution

Otc - Questions

Questions or comments?
Call 1-855-333-6337

Other

Repackaged by:
Safecor Health LLC
317 New Boston St.
Woburn, MA 01801
Distributed by:
LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33123

Package Label.Principal Display Panel



———PRINCIPAL DISPLAY PANEL———
NDC: 24451-091-30
ALUMINUM HYDROXIDE
GEL, USP
1920 mg / 30 mL
DELIVERS 30 mL
SUGAR FREE
MINT FLAVOR
SHAKE WELL BEFORE USING
Exp: 00/00/00 Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

Product Label (Product Label)

Product Label (Product Label)

* Please review the disclaimer below.