NDC 69016-001 Relief Otc Antacid
NDC Product Code 69016-001
Proprietary Name: Relief Otc Antacid What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
NDC Code Structure
- 69016 - Tummy Company, Inc.
- 69016-001 - Relief Otc Antacid
NDC 69016-001-18
Package Description: 118 mL in 1 BOTTLE
NDC 69016-001-54
Package Description: 354 mL in 1 BOTTLE
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’.
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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)
- 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
- Other Information
- Inactive Ingredients
- Representative Label
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.