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/antigas Suspension
FDA Label NDC 68071-5289
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals, Inc. for the product Regular Strength Antacid/antigas (NDC 68071-5289). 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
Ask a doctor before use if you have
- kidney disease
- a magnesium-restricted diet
Ask a doctor or pharmacist before use if you arepresently taking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor ifsymptoms last more than 2 weeks
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 each use
• adults and children 12 years and older: take 10 mL to 20 mL
(1-2 doses) four times a day or as directed by a doctor
• do not exceed 80 mL (8 doses) in a 24 hour period 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, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
Questions Or Comments?
1-800-540-3765
Package Label
Pdp (68071 5289 1)
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