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Nutralox - Medication Information

Product NDC Code 50332-0151
Drug Name

Nutralox

Type Brand
Pharm Class Blood Coagulation Factor [EPC],
Calcium [CS],
Cations,
Divalent [CS],
Increased Coagulation Factor Activity [PE],
Phosphate Binder [EPC],
Phosphate Chelating Activity [MoA]
Active Ingredients
Calcium carbonate 420 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 313884,
1358869
Application Number part331
Labeler Name HART Health
Packages
Package NDC Code Description
50332-0151-1 500 packet in 1 box, unit-dose (50332-0151-1) / 2 tablet, chewable in 1 packet
50332-0151-3 20 packet in 1 box, unit-dose (50332-0151-3) / 2 tablet, chewable in 1 packet
50332-0151-4 50 packet in 1 box, unit-dose (50332-0151-4) / 2 tablet, chewable in 1 packet
50332-0151-7 125 packet in 1 box, unit-dose (50332-0151-7) / 2 tablet, chewable in 1 packet
50332-0151-8 250 packet in 1 box, unit-dose (50332-0151-8) / 2 tablet, chewable in 1 packet
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each tablet): Calcium Carbonate 420 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions: Do not take more than directed Adults and children 12 years of age and over: thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur do not take more than 16 tablets in 24 hours unless directed by a doctor do not use the maximum dose for more than 2 weeks Children under 12 years of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients aspartame, croscarmellose sodium, magnesium stearate, maltodextrin, mint flavor, sorbitol May contain mineral oil

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses: Temporarily relieves heartburn sour stomach acid indigestion upset stomach

Purpose

Information about the drug product’s indications for use.
Purpose: Antacid

Spl product data elements

Usually a list of ingredients in a drug product.
NUTRALOX CALCIUM CARBONATE CALCIUM CARBONATE CALCIUM CATION ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MALTODEXTRIN MINERAL OIL SORBITOL AZ;036

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Nutralox.jpg

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interfere with certain prescription drugs.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information: Calcium content per tablet: 168mg phenylketonurics: each tablet may contain 1.5 mg phenylalanine tablets enclosed in a sealed packet do not use if packet is torn, cut or open store at 59° to 86°F (15°-30°C) avoid excessive heat and humidity

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if symptoms last for more than 2 weeks

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding , ask a health professional before use

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings:

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API