Otc - Active Ingredient
ACTIVE INGREDIENT IN EACH TABLET- CALCIUM CARBONATE 420 MG
Magnacal
FDA Label NDC 51532-0303
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Afassco Inc. for the product Magnacal (NDC 51532-0303). 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 the following symptoms associated with:
• acid indigestion • sour stomach
• heartburn • upset stomach
Warnings
Warnings:
Ask a doctor or health professional before use if you are:
• taking a prescription drug. Antacids may interact with certain prescription drugs.
• do not use a maximum dosage for more than 2 weeks except under the advice of a physician.
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 and older) 2 or more tablets chewed not to exceed18 tablets in a 24 hour period
Children: (under 12 years) Do not give to children under 12 years of age unless directed by a doctor.
Inactive Ingredient
SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION
Other Safety Information
Other Information:
Each tablet contains: 168 mg of elemental calcium.
Package Label.Principal Display Panel
Afasscomagnacal12-16 (Afassco Magnacal)
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