Otc - Active Ingredient
Active Ingredient (in each chew)
Calcium carbonate 750 mg
Flavor Chews
FDA Label NDC 0363-0011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Flavor Chews (NDC 0363-0011). 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.
Do not take more than 5 chews in a 24 hour period, or use the maxiumum dosage for more than 2 weeks, except under the advice and supervision of a physician.
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
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 year sand older chew and swallow 1 to 2 chews every 2-4 hours as needed. Do not exceed 5 chews in 24 hours. Children under 12 years consult a doctor.
Inactive Ingredient
Inactive ingredients
Beeswax, carmine, carnauba wax, citric acid, 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, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide. Soybean oil and corn starch are used as processing aids.
Other Safety Information
Other information
- Each chew contains: calcium 300mg, magnesium 1mg
- Contains soy
- Store between 20 to 25 C (68 to 77 F) in a dry place
Otc - Questions
Questions?
Call 1-800-245-2898 Monday - Friday 9AM - 4PM EST
* Please review the disclaimer below.
