Regular Strength Antacid Mint Liquid
FDA Label NDC 36800-582

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Regular Strength Antacid Mint (NDC 36800-582). 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 10 ml ), purpose, use(s), warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 10 Ml )

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg
Magnesium hydroxide 400 mg
Simethicone 40 mg

Purpose

Antacid
Antacid
Antigas

Use(S)

relieves:


  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach and gas associated with these symptoms 

Warnings

Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

Ask A Doctor Before Use If You Have

  • kidney disease
  • a magnesium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop Use And Ask Doctor

if symptoms last more than two weeks

Keep Out Of Reach Of Children

.

Directions

  • shake well before use
  • adults and children 12 years and older: take 10 mL to 20 mL four times a day, or as directed by a doctor
  • children under 12 years: consult a doctor
  • mL = milliliter

Other Information

  • each 10 mL contains: magnesium 170 mg, sodium 5 mg
  • store at 20°C-25°C (68°-77°F)
  • do not freeze

Inactive Ingredients

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

Principal Display Panel

Topcare Health
NDC 36800-582-40

REGULAR STRENGTH

Antacid

Advanced

ANTACID & ANTIGAS

FAST RELIEF

  • Heartburn
  • Acid Indigestion
  • Pressure
  • Bloating (Gas)

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    ALCOHOL 0.4% v/v


    12 FL OZ (355 mL)
    MINT FLAVOR



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