FDA Label for Antacid Fruit Chews
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTHER SAFETY INFORMATION
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Antacid Fruit Chews Product Label
The following document was submitted to the FDA by the labeler of this product American Sales. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each chew)
Calcium carbonate 750 mg
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 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
When using this product constipation may occur.
Other Safety Information
Each chew contains: calcium 300 mg, magnesium 1 mg
Contains soy
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 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 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 (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, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, and titanium dioxide.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9AM to 4PM EST
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