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| Product NDC Code | 0280-0001 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Alka-seltzer cool action heartburn relief mint |
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| 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] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | GUM, CHEWING | ||||||||||
| RxCUI drug identifier | 2281777 | ||||||||||
| Application Number | M001 | ||||||||||
| Labeler Name | Bayer HealthCare LLC. | ||||||||||
| 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 chewing piece) 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 Directions ● adults and children 12 years and over: chew 1 - 2 pieces as symptoms occur or as directed by a doctor ● children under 12 years: consult a doctor ● do not use more than 5 pieces in a 24-hour period ● if pregnant, do not use more than 5 pieces in 24-hour period ● do not swallow the gum
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, butylated hydroxytoluene, copovidone, FD&C Blue No.1 Aluminum Lake, flavors, gum base, isomalt, magnesium stearate, sorbitol, sucralose, talc, titanium dioxide
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 Uses for the relief of: ● acid indigestion ● heartburn ● sour stomach ● 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.Alka-Seltzer Cool Action Heartburn Relief Mint Calcium Carbonate ISOMALT SORBITOL ACESULFAME POTASSIUM ACESULFAME TITANIUM DIOXIDE CALCIUM CARBONATE CALCIUM CATION SUCRALOSE MAGNESIUM STEARATE FD&C BLUE NO. 1--ALUMINUM LAKE COPOVIDONE K25-31 BUTYLATED HYDROXYTOLUENE TALC 750 Blue and white; Active on white
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.Carton count 16 pieces Works Fast! Alka-Seltzer® Calcium Carbonate/ Antacid EXTRA STRENGTH COOL ACTION HEARTBURN RELIEF GUM cool mint 16 pieces 16 count carton
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 or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have ever had an allergic reaction to this product or any of its ingredients
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ● each piece contains: calcium 300 mg ● store at room temperature. Avoid humidity and excessive heat above 40ºC (104ºF).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
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 use more than 5 pieces in a 24-hour period ● if pregnant do not use more than 5 pieces in a 24-hour period ● do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, inform your doctor that you are using this product.
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 Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product ● do not use more than 5 pieces in a 24-hour period ● if pregnant do not use more than 5 pieces in a 24-hour period ● do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician If pregnant or breast-feeding, inform your doctor that you are using this product. Keep out of reach of children.
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