Otc - Active Ingredient
ACTIVE INGREDIENT IN EACH TABLET- CALCIUM CARBONATE 420 MG
Mint Antacid
FDA Label NDC 67060-303
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced First Aid, Inc. for the product Mint Antacid (NDC 67060-303). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
ANTACID
Indications & Usage
Uses:
for the relief of:
•heartburn • sour stomach • acid indigestion
Warnings
Warnings:
Do not:
•Take more than 18 tablets in a 24 hour period, or use the maximum dosage of
this product for more than 2 weeks, except under the advice of a physician.
Stop use and ask a doctor if:
•You are currently taking any prescription drug. Antacids may react with certain
prescription drugs.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical
attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions:
Adults and children 12 years of age and older: Take 2 tablets every 4 to
6 hours or as needed, do not exceed 18 tablets in 24 hours, or asdirected by a doctor.
Children under 12 years: Consult a doctor.
Inactive Ingredient
Inactive Ingredients: corn starch, flavor, invert sugar, magnesium stearate, silicon dioxide, starch and sucrose.
Package Label.Principal Display Panel
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