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| Product NDC Code | 70000-0431 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader extra strength antacid |
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| Type | Brand | ||||
| Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 308915 | ||||
| Application Number | part331 | ||||
| Labeler Name | CARDINAL HEALTH 110, LLC. DBA LEADER | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT (in each tablet) Calcium carbonate 750 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 adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS corn starch, crospovidone, D&C red 27 lake, D&C yellow 10 lake, dextrose, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.
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(S) relieves: acid indigestion heartburn
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.Leader Extra Strength Antacid Calcium carbonate CALCIUM CARBONATE CALCIUM CATION STARCH, CORN CROSPOVIDONE DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN SUCROSE TALC D&C RED NO. 27 D&C YELLOW NO. 10 FD&C YELLOW NO. 6 reddish pink G127 punch
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 LEADER NDC 70000-0431-1 Extra Strength Antacid Tablets Calcium Carbonate 750 mg Tropical Fruit Flavor COMPARE TO TUMS® EXTRA STRENGTH active ingredient* Relief of : Acid Indigestion Heartburn 96 CHEWABLE TABLETS 117
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 interact 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 .
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.WHEN USING THIS PRODUCT do not take more than 10 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.
Pregnancy or breast feeding
Pregnancy or Breast feedingIF PREGNANT OR/BREASTFEEDING, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION each tablet contains: elemental calcium 300 mg do not use if printed seal under cap is torn or missing. store at room temperature. Keep the container tightly closed.
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