Otc - Active Ingredient
Active Ingredient (per tablet)
Calcum Carbonate USP 250mg
Antacid Melts Lozenge
FDA Label NDC 68229-800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quest Products, Llc for the product Antacid Melts (NDC 68229-800). 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, uses, ask a doctor before use if you are:, when using this product, keep out of reach of children, if pregnant or breast-feeding,, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antacid
Uses
Relieves:
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
Ask A Doctor Before Use If You Are:
- Presently taking a prescription drug. Antacids may interact with certain prescription drugs.
- Some people have or may develop a sensitivity to acacia gum. If mouth irritation develops, discontinue use.
When Using This Product
do not take more than 24 tablets in 24 hours. Do not use maximum dosage for more than 2 weeks unless under the advice or supervision of a doctor.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Cemter right away
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions
Adults and children 12 years of age and older: Affix 1 or 2 tablets as directed below and allow to slowly dissolve in the mouth. May be repeated as needed, up to a maximum of 24 tablets per day. This product may last over 2 hours. May be used in daytime or nighttime.
Children under 12 years of age: Ask a doctor.
Placement: Antacid Melts are bi-layered tablets with a dimple on the tan (darker) side and antacid on the white (lighter) side.marked CA. Place the adhesive side with a dimple on the outside of a molar and/or adjoining gum, upper or lower, or on braces or appliances. Hold the tablet in place with your cheek or tongue for 10 seconds to initiate adhesion. Adhesion will strengthen over the next few minutes. The tablet may be removed at any time.
Other Information
- Each lozenge conatins elementail calcium 100mg
- Avoid humidity
- Store at 15°C - 30°C (59° - 86°F)
- Do not use if foil under cap/blister pack is damaged , missing or broken
Inactive Ingredients
Acacia Gum, Cellulose Gum, Magnesium Stearate, Maltodextrin, Natural & Artificial Flavor, Sodium Bicarbonate, Sorbitol, Sucralose
40 Count Blister/Carton Ndc 68299-800-40
40ctpdp (800 40pdp)
80 Count Bottle Ndc 68299-800-80
80ctpdp (800 80pdp)
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