NDC 69016-001 Relief Otc Antacid

NDC Product Code 69016-001

NDC 69016-001-18

Package Description: 118 mL in 1 BOTTLE

NDC 69016-001-54

Package Description: 354 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Relief Otc Antacid with NDC 69016-001 is a product labeled by Tummy Company, Inc.. The generic name of Relief Otc Antacid is . The product's dosage form is and is administered via form.

Labeler Name: Tummy Company, Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Tummy Company, Inc.
Labeler Code: 69016
Start Marketing Date: 05-28-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Relief Otc Antacid Product Label Images

Relief Otc Antacid Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each 4 Oz Dose)

Calcium carbonate USP 545mgPotassium bicarbonate USP 905mgSodium bicarbonate USP 2110mg

Purpose

AntacidAntacidAntacid

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 tightlyDo not exceed daily recommended dosageShake 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 640mgEach 4 oz Dose contains: potassium 353mgEach 4 oz Dose contains: calcium 218mgStore below 86 degrees F (30 degrees C)

Inactive Ingredients

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

Representative Label

  • New!Fast heartburn ReliefOTCantacidgreat tastingORANGE CREME12 fl. oz. (354 mL)Fast Heartburn Relief Begins with One Sip!Heartburn Relief that's Easy to Swallow.A Great Tasting, Non-Chalky, Clear LiquidTake RELIEF OTC ANYTIME forHearburnAcid IndigestionUpset StomachGLUTEN-FREEALUMINUM-FREEASPIRIN-FREEDistributed byTummy Company, Inc.Phoenix,AZ 850542014 Made in the USA

* Please review the disclaimer below.