Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Calcium Carbonate 750 mg
Antacid Fruit Flavor Chews
FDA Label NDC 55319-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar for the product Antacid Fruit Flavor Chews (NDC 55319-017). 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 - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antacid
Indications & Usage
Uses Relieves
Heartburn
Sour stomach
Acid indigestion
Upset stomach due to these symptoms
Warnings
Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.
Otc - When Using
Do not take more than 5 chewable tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the supervision of a physician.
When using this product constipation may occur.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
Adults and children 12 years and older chew and swallow 1 to 2 chewable tablets every 2-4 hours as needed. Do not exceed 5 chewable tablets in 24 hours. Children under 12 years consult a doctor.
Other Safety Information
Other information
Each chewable tablet contains: calcium 300 mg, magnesium 1 mg
Contains soy
Contains FD&C Yellow No. 5 (tartrazine) as a color additive
Inactive Ingredient
Inactive ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 lake (tartrazine), FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, propyl paraban, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose and titanium dioxide.
Otc - Questions
Questions? Call 1-800-245-2898 Monday - Friday, 9AM to 4PM EST
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