Relief Otc Antacid
FDA Label NDC 69016-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tummy Company, Inc. for the product Relief Otc Antacid (NDC 69016-001). 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 4 oz dose), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, stop use and ask a doctor, if pregnant or breastfeeding,, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 4 Oz Dose)

Calcium carbonate USP 545mg

Potassium bicarbonate USP 905mg

Sodium bicarbonate USP 2110mg

Purpose

Antacid

Antacid

Antacid

Uses

for the relief of

• Heartburn  • Acid Indigestion • Sour Stomach

Ask A Doctor Before Use If You Have

•Kidney Disease

•A Potassium or Sodium-Restricted Diet

Ask A Doctor Or Pharmacist Before Use If You

are currently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop Use And Ask A Doctor

if you have taken the maximum dose for 2 weeks.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Directions

  • Do not use if outer seal is broken, replace cap tightly
  • Do not exceed daily recommended dosage
  • Shake well & drink 2-4 ounces as symptoms occur
    •  Adults and children 12 years and over Up to 4oz. every 4 hours as sumptoms occur or as prescribed by a doctorDo not exceed 16 ounces in 24 hours 
     Adults 60 and overUp to 4oz. every 4 hours as sumptoms occur or as prescribed by a doctor Do not exceed 12 ounces in 24 hours
     Children under 12 years Ask a doctor

Other Information

  • Each 4 oz Dose contains: sodium 640mg
  • Each 4 oz Dose contains: potassium 353mg
  • Each 4 oz Dose contains: calcium 218mg
  • Store below 86 degrees F (30 degrees C)

Inactive Ingredients

magnesium hydroxide, metyl paraben, natural flavors, propyl paraben, purified water, sucralose

Questions Or Comments?

1-888-959-6207 weekdays

reliefotc.com

Representative Label

New!

Fast heartburn Relief

OTC

antacid

great tasting

ORANGE CREME

12 fl. oz. (354 mL)

Fast Heartburn Relief Begins with One Sip!

Heartburn Relief that's Easy to Swallow.

A Great Tasting, Non-Chalky, Clear Liquid

Take RELIEF OTC ANYTIME for

  • Hearburn
  • Acid Indigestion
  • Upset Stomach

    • GLUTEN-FREE
    • ALUMINUM-FREE
    • ASPIRIN-FREE

      • Distributed by

      Tummy Company, Inc.

      Phoenix,

      AZ 85054

      2014 Made in the USA

      Reliefotcantacid12oz (Reliefotcantacid12oz)

      Reliefotcantacid12oz (Reliefotcantacid12oz)

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