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| Product NDC Code | 0280-0058 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Alka-seltzer cool action extra strength reliefchews 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 | TABLET, CHEWABLE | ||||||
| RxCUI drug identifier | 308915 | ||||||
| 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 chewable 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 Directions ● adults and children 12 years and over: fully chew then swallow 2 to 4 chewable tablets as symptoms occur, or as directed by a doctor ● children under 12 years: consult a doctor ● do not take more than 5 chewable tablets in a 24-hour period ● if pregnant, do not take more than 5 chewable tablets in 24 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carnauba wax, citric acid, coconut oil, corn syrup, dextrin, FD&C Blue No.1, FD&C Blue No.1 Aluminum Lake, FD&C Red No.40 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, flavors, glycerin, gum arabic, lecithin, maltodextrin, mono and diglycerides, potassium sorbate, propylene glycol, purified water, shellac, sorbic acid, sucrose, titanium dioxide, vegetable oil, white wax, xylitol
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 Extra Strength ReliefChews Mint Calcium Carbonate CORN SYRUP PROPYLENE GLYCOL SHELLAC WHITE WAX FD&C BLUE NO. 1 FD&C BLUE NO. 1--ALUMINUM LAKE MALTODEXTRIN TITANIUM DIOXIDE SUCROSE SORBIC ACID XYLITOL POTASSIUM SORBATE CALCIUM CARBONATE CALCIUM CATION CARNAUBA WAX COCONUT OIL GLYCERIN WATER AS
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.Bottle label 30 tablets Starts Neutralizing Acid in Seconds! NEW Cooling Sensation Alka-Seltzer® Calcium Carbonate/Antacid EXTRA STRENGTH COOL ACTION HEARTBURN RELIEFCHEWS® cool mint 30 Chewable Tablets AS Cool Action Relief Chews Mint bottle label
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.
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 Other information ● each chewable tablet contains : calcium 300 mg ● store at room temperature. Avoid excessive heat above 40ºC (104ºF). ● avoid excessive humidity ● close cap tightly after use
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 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 take more than 5 chewable tablets in a 24-hour period ● if pregnant do not take more than 5 tablets in 24 hours ● 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 take more than 5 chewable tablets in a 24-hour period ● if pregnant do not take more than 5 tablets in 24 hours ● 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