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Calcium carbonate - Medication Information

Product NDC Code 0395-0431
Drug Name

Calcium carbonate

Type Generic
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 1 g/g
Route ORAL
Dosage Form POWDER
Application Number M001
Labeler Name Humco Holding Group, Inc.
Packages
Package NDC Code Description
0395-0431-01 454 g in 1 bottle, plastic (0395-0431-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Calcium Carbonate

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 Adults and children 6 yrs. of age and older: Take 1/2 level tsp. in 1/2 glass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients None

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.
Use For relief of heartburn, acid ingestion, and upset stomach associated with these symptoms.

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.
Calcium Carbonate Calcium Carbonate WATER CALCIUM CARBONATE CALCIUM CATION

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.
Principal Display Panel CalCarb.jpg

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you are preganant or nursing a baby.

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 accidental overdose, seek professional assistance or contact a Poison Control immediately.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
do not use the maximum dosge of this product for more than 2 weeks except under the advice and supervision of a doctor or other health professional.

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 Except under the supervision of a doctor: do not administer to children under 6 years of age. do not take more than 3 teaspoonfuls in a 24 hour period.

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