Calcium carbonate

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

# Overview
Calcium carbonate is an antacid that is FDA approved for the treatment of heartburn, sour stomach, acid indigestion, upset stomach associated with these symptoms.   Common adverse reactions include constipation, flatulence, swollen abdomen.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

# Indications
- Calcium deficiency; Prophylaxis

# Dosage
- Calcium deficiency; Prophylaxis: 19 to 50 years, RDA is 1000 mg elemental calcium per day in divided doses of 500 mg or less each; max 2500 mg per day.
- Calcium deficiency; Prophylaxis: 51 to 70 years (men), RDA is 1000 mg elemental calcium per day in divided doses of 500 mg or less each; max 2000 mg per day.
- Calcium deficiency; Prophylaxis: 51 to 70 years (women), RDA is 1200 mg elemental calcium per day in divided doses of 500 mg or less each; max 2000 mg per day.
Calcium deficiency; Prophylaxis: greater than 70 years, RDA is 1200 mg elemental calcium per day in divided doses of 500 mg or less each; max 2000 mg per day.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Calcium carbonate in adult patients.

### NonGuideline-Supported Use

# Indications
- Chemical burn, Hydrofluoric acid
- Fracture of bone; Prophylaxis
- Heartburn
- Hypocalcemia, Chronic
- Postmenopausal osteoporosis

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

# Indications
Calcium deficiency; Prophylaxis

# Dosage
- Calcium deficiency; Prophylaxis: 0 to 6 months, RDA is 200 mg elemental calcium per day; max 1000 mg per day.
- Calcium deficiency; Prophylaxis: 6 to 12 months, RDA is 260 mg elemental calcium per day; max 1500 mg per day.
- Calcium deficiency; Prophylaxis: 1 to 3 years, RDA is 700 mg elemental calcium per day; max 2500 mg per day.
- Calcium deficiency; Prophylaxis: 4 to 8 years, RDA is 1000 mg elemental calcium per day; max 2500 mg per day.
- Calcium deficiency; Prophylaxis: 9 to 13 years, RDA is 1300 mg elemental calcium per day; max 3000 mg per day.
Calcium deficiency; Prophylaxis: 14 to 18 years, RDA is 1300 mg elemental calcium per day; max 3000 mg per day.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Calcium carbonate in adult patients.

### NonGuideline-Supported Use

# Indications
- Heartburn

# Contraindications
There is limited information regarding Calcium carbonate Contraindications in the drug label.

# Warnings
Ask a doctor before use if you have
- Kidney stones
- A calcium-restricted diet
Ask a doctor or pharmacist before use if you are
- Now taking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product
- Do not take more than 10 tablets in 24 hours
- Do not use the maximum dosage for more than 2 weeks
Keep out of reach of children.

# Adverse Reactions

## Clinical Trials Experience

# Common
Gastrointestinal:
- Constipation
- Flatulence
- Swollen abdomen

# Serious
Cardiovascular
- Myocardial infarction
Renal
- Urolithiasis
Reproductive
- Prostate cancer
Other
- Milk alkali syndrome

## Postmarketing Experience
There is limited information regarding Calcium carbonate Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Calcium carbonate Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Calcium carbonate in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calcium carbonate in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Calcium carbonate during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Calcium carbonate in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Calcium carbonate in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Calcium carbonate in geriatric settings.

### Gender
There is no FDA guidance on the use of Calcium carbonate with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Calcium carbonate with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Calcium carbonate in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Calcium carbonate in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Calcium carbonate in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Calcium carbonate in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Calcium carbonate Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Calcium carbonate and IV administrations.

# Overdosage
There is limited information regarding Calcium carbonate overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
There is limited information regarding Calcium carbonate Mechanism of Action in the drug label.

## Structure
There is limited information regarding Calcium carbonate Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Calcium carbonate Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Calcium carbonate Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Calcium carbonate Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Calcium carbonate Clinical Studies in the drug label.

# How Supplied
There is limited information regarding Calcium carbonate How Supplied in the drug label.

## Storage
- Store at 20 - 25C (68 - 77F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Calcium carbonate Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Calcium carbonate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- REGULAR STRENGTH ANTACID CALCIUM SUPPLEMENT 

# Look-Alike Drug Names
There is limited information regarding Calcium carbonate Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price