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Product NDC Code | 63868-565 | ||||
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Drug Name | Heartburn relief |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | SUSPENSION | ||||
RxCUI drug identifier | 245001 | ||||
Application Number | M001 | ||||
Labeler Name | CHAIN DRUG MARKETING ASSOCIATION | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each 5 mL teaspoonful) Aluminum hydroxide 254 mg Magnesium carbonate 237.5 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 shake well before use adults and children 12 years and older take 2-4 teaspoonsful four times a day or as directed by a doctor children under 12 years: consult a doctor take after meals and at bedtime dispense product only by spoon or other measuring device
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, edetate disodium, flavor, glycerin, purified water, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, xanthan gum
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 relieves heartburn sour stomach acid indigestion 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.HEARTBURN RELIEF aluminum hydroxide and magnesium carbonate BENZYL ALCOHOL EDETATE DISODIUM GLYCERIN WATER SACCHARIN SODIUM SODIUM ALGINATE SORBITOL XANTHAN GUM ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM CARBONATE CARBONATE ION DIMETHICONE
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.package Label 1
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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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? 1-800-540-3765
Storage and handling
Information about safe storage and handling of the drug product.Other information each 5 mL teaspoonful contains: magnesium 70 mg, sodium 16 mg store at room temperature protect from freezing keep tightly closed TAMPER-EVIDENT : Do not use this product if inner foil seal over mouth of the bottle is broken or missing.
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 Ask a doctor before use if you have kidney disease a magnesium-restricted diet a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product laxative effect may occur do not use maximum dosage for more than 2 weeks do not take more than 16 teaspoonfuls in 24 hours If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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