Active Ingredient (In Each 5 Ml Teaspoonful)
Aluminum hydroxide 320 mg
Aluminum Hydroxide Liquid
FDA Label NDC 0536-0091
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Aluminum Hydroxide (NDC 0536-0091). 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 active ingredient (in each 5 ml teaspoonful), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
relieves
- heartburn
- acid indigestion
- sour stomach
Warnings
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
When using this product you may get constipated
Stop use and ask a doctor if symptoms last more than 2 weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 Information
- store at room temperature
- protect from freezing
- keep tightly closed
- TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients
benzyl alcohol, butylparaben, flavor, glycerin, hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol solution
Questions Or Comments?
1-800-645-2158
Package Label
compare to the active ingredient in AMPHOJEL
Rugby
NDC 0536-0091-85
MINT FLAVOR
Aluminum Hydroxide Gel, USP
ANTACID
SUGAR FREE
This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
Rugby Laboratories, INC. is not affiliated with the owner of the trademark Amphojel.
16 fl oz (473 mL)
* Please review the disclaimer below.
