Active Ingredient (In Each Tablet) Purpose
Calcium Carbonate 420 mg................................................................................................................................antacid
Mint Flavored Antacid
FDA Label NDC 71105-303
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redicare Llc for the product Mint Flavored Antacid (NDC 71105-303). 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 active ingredient (in each tablet) purpose, uses:, warnings:, stop use and ask a doctor if:, if pregnant or breast-feeding baby, keep out of reach of children., directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
for the relief of: ■ heartburn ■ sour stomach ■ acid indigestion
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.
If Pregnant Or Breast-Feeding Baby
ask a health professional before use.
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.
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 as directed by a doctor Children under 12 years: Consult a doctor.
Other Information:
■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity ■ Each tablet contains: 168mg of elemental calcium
Inactive Ingredients:
acacia gum, corn starch, flavor, invert sugar, magnesium stearate, silicon dioxide, starch and sucrose.
Package Label.Principal Display Panel
Antacid Box (Antacid Box 81632)
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