Active Ingredients (In Each 5 Ml Teaspoonful)
Aluminum hydroxide 254 mg
Magnesium carbonate 237.5 mg
Extra Strength Heartburn Relief Suspension
FDA Label NDC 70000-0363
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Extra Strength Heartburn Relief (NDC 70000-0363). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml teaspoonful), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
relieves
- heartburn
- sour stomach
- acid indigestion
- upset stomach associated with these symptoms
Warnings
Ask a doctor before use if you have
- kidney disease
- a magnesium-restricted diet
- a sodium-restricted diet
- laxative effect may occur
- do not use maximum dosage for more than 2 weeks
- do not take more than 16 teaspoonfuls in 24 hours
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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away
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
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.
Inactive Ingredients
benzyl alcohol, edetate disodium, flavor, glycerin, purified water, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, xanthan gum
Questions Or Comments?
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Package Label
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