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| Product NDC Code | 0280-0224 | ||||
|---|---|---|---|---|---|
| Drug Name | Alka-seltzer heartburn reliefchews strawberry and orange |
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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 adults and children 12 years and over: chew and swallow 1-2 chewable tablets every 2 to 4 hours as symptoms occur, or as directed by a doctor children under 12 years: consult a doctor do not take more than 10 chewable tablets in a 24-hour period
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, FD&C yellow #6, flavors, hydrogenated coconut oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propylene glycol, propyl paraben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, vegetable oil, white wax
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 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 Heartburn ReliefChews Strawberry and Orange CALCIUM CARBONATE ACACIA CARNAUBA WAX CITRIC ACID MONOHYDRATE STARCH, CORN CORN SYRUP FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 ALUMINUM OXIDE HYDROGENATED COCONUT OIL MEDIUM-CHAIN TRIGLYCERIDES METHYLPARABEN PHOSPHORIC ACID PROPYLENE GLYCOL WATER SHELLAC SODIUM BENZOATE SORBIC ACID SORBITOL SUCROSE TITANIUM DIOXIDE WHITE WAX CALCIUM CARBONATE CALCIUM CATION 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.PRINCIPAL DISPLAY PANEL - 6 Tablet Blister Pack Carton ON-THE-GO PACK PEEL strawberry & orange Alka- Seltzer ® Calcium Carbonate /Antacid EXTRA STRENGTH HEARTBURN RELIEFCHEWS ™ 6 CHEWABLE TABLETS Label 6
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
Dist. by: Bayer HealthCare LLC Whippany, NJ 07981
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.
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) or www.alkaseltzer.com
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 chewable tablets 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 constipation may occur
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each chewable tablet contains: calcium 300 mg store at room temperature. Avoid excessive heat above 40°C (104°F).
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 10 chewable tablets 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 constipation may occur If pregnant or breast-feeding, ask a health professional before use. 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