Active Ingredients (In Each 10 Ml Dose)
Aluminum hydroxide 400 mg (equivalent to dried gel, USP)
Magnesium hydroxide 400 mg
Simethicone 40mg
Regular Strength Antacid Liquid
FDA Label NDC 46122-433
9 label sections · Submitted to the FDA by Amerisourcebergen Drug Corporation · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisourcebergen Drug Corporation for the product Regular Strength Antacid (NDC 46122-433). 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 ingredients (in each 10 ml dose), purposes, 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
Purposes
Antacid
Antigas
Uses
relieves
- heartburn
- sour stomach
- acid indigestion
- the symptoms referred to as gas
Warnings
Do not take more than 120 mL (12 doses) in a 24 hour period or use
the maximum dosage for more than 2 weeks.
Ask a doctor before use if you have
- kidney disease
- a magnesium-restricted diet
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- shake well before use
- adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
- do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
- children under 12 years: ask a doctor
Other Information
- each 10 mL dose contains: magnesium 165 mg, sodium 6 mg
- store at room temperature
- protect from freezing
- keep tightly closed
Inactive Ingredients
benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
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