Active Ingredient (In Each Tablet)
Calcium Carbonate 420 mg
Belmora Melox Agrura Tablet, Chewable
FDA Label NDC 27854-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Belmora, Llc for the product Belmora Melox Agrura (NDC 27854-120). 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 active ingredient (in each tablet), purpose, uses, do not use, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, 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
Purpose
Antacid
Uses
For the relief of the following symptoms
■ acid indigestion
■ sour stomach
■ heartburn
■ upset stomach associated with these symptoms
Do Not Use
■ the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a
physician or take more than 19 tablets in a 24 hour period.
Ask A Doctor Or Pharmacist Before Use If You Are
■ presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop Use And Ask A Doctor If
■ symptoms last more than 2 weeks
If Pregnant Or Breast Feeding,
ask a health professional before use.
Directions
■ do not use more than directed
■ chew or crush tablets completely before swallowing
■ do not swallow tablets whole
Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as
directed by a physician. Do not exceed 19 tablets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age.
Other Information
■ phenylketonurics: may contain phenylalanine 1.5 mg per tablet
■ each tablet contains 168 mg of elemental calcium
■ store at room temperature 59-86°F (15-30°C) in a dry place
■ tamper-evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredients
aspartame, croscarmellose sodium, magnesium stearate, maltodextrin, mineral oil, sorbitol
Questions Or Comments?
Call 1-800-779-2877 M-F 9AM-5PM EST
Belmora Melox
NDC 27854-120-01
Belmora LLC
Melox
Agrura/Heartburn
Chew or Crush Tablets Completely Before Swallowing
Masticar o Triturar Completamente Las Tabletas Antes De Tragar
Antacid/Calcium Carbonate
Antiacido/Carbonato De Calcio
Heartburn, Indigestion
Calcium Carbonate 420MG
Las Aguras, La Indigestion
Carbonato De Calco 420MG
100 Tablets/50-Dual Packets/1 Tablets per Packet
Tamper Evident Unit Dose Packets/Empacquetado con Sellado Evidente en Dosis Unitarias
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