Antacid Liquid
FDA Label NDC 72476-516

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Retail Business Services, Llc. for the product Antacid (NDC 72476-516). 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 ingredient (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 Ingredient (In Each 10 Ml )

Aluminum hydroxide (equiv. to dried gel, USP) 800 mg
Magnesium hydroxide 800 mg
Simethicone 80 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 60 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 - 20 mL two 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 340 mg, sodium 5 mg
  • store at controlled room temperature 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

CAREONE
NDC 72476-516-05

Compare to the active ingredients in Mylanta® Maximum Strength

MAXIMUM STRENGTH

ANTACID LIQUID


Aluminum Hydroxide 800mg

Magnesium Hydroxide 800mg

Simethicone 80mg


Original Flavor


Relieves: 

Acid Indigestion, Pressure & Bloating (Gas)

 


12 FL OZ (355 mL)
Alcohol content 0.2% v/v 

79 (516)

79 (516)




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