Relief OTC antacid

Manufacturer
Tummy Company, Inc. | Alera Technologies Inc.
Effective date
2014-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:25

Label at a glance#

ProductRelief OTC antacid
Active ingredientCALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE
Label structure9 sections

Indications and uses

for the relief of • Heartburn  • Acid Indigestion • Sour Stomach

Dosage and administration

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 doctor Do not exceed 16 ounces in 24 hours   Adults 60 and over Up to 4oz. every 4 hours as sumptoms occur or as prescribed by a doctor  Do not exceed 12 ounces in 24 hou...

Storage and handling

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)

Label contents#

Full prescribing information#

Active ingredients (in each 4 oz Dose)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate USP 545mg

Potassium bicarbonate USP 905mg

Sodium bicarbonate USP 2110mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antacid

Antacid

Uses

INDICATIONS & USAGE SECTION

for the relief of

• Heartburn  • Acid Indigestion • Sour Stomach

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

•Kidney Disease

•A Potassium or Sodium-Restricted Diet

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop Use and ask a doctor

OTC - STOP USE SECTION

if you have taken the maximum dose for 2 weeks.

If pregnant or breastfeeding,

SPL UNCLASSIFIED SECTION

ask a health professional before use.

Keep this out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-959-6207 weekdays

reliefotc.com

Representative Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

ReliefOTCAntacid12ozReliefOTCAntacid12oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1538288calcium 545 MG / potassium 905 MG / sodium bicaronate 2110 MG in 118 mL Oral SuspensionPSN1
1538294Fast Heartburn Relief OTC 545 MG / 905 MG / 2110 MG in 118 mL Oral SuspensionPSN1
1538294calcium carbonate 4.62 MG/ML / potassium bicarbonate 7.67 MG/ML / sodium bicarbonate 17.9 MG/ML Oral Suspension [Fast Heartburn Relief OTC]SBD1
1538288calcium carbonate 4.62 MG/ML / potassium bicarbonate 7.67 MG/ML / sodium bicarbonate 17.9 MG/ML Oral SuspensionSCD1
1538288calcium 545 MG / potassium 905 MG / sodium bicaronate 2110 MG per 118 ML Oral SuspensionSY1
1538288Calcium Carbonate 4.62 MG/ML / K+ bicarbonate 7.67 MG/ML / NaHCO3 17.9 MG/ML Oral SuspensionSY1
1538294Calcium Carbonate 4.62 MG/ML / K+ bicarbonate 7.67 MG/ML / NaHCO3 17.9 MG/ML Oral Suspension [Fast Heartburn Relief OTC]SY1
1538288Calcium Carbonate 4.62 MG/ML / Pot bicarbonate 7.67 MG/ML / NaHCO3 17.9 MG/ML Oral SuspensionSY1
1538294Calcium Carbonate 4.62 MG/ML / Pot bicarbonate 7.67 MG/ML / NaHCO3 17.9 MG/ML Oral Suspension [Fast Heartburn Relief OTC]SY1
1538294Fast Heartburn Relief OTC (calcium carbonate 545 MG / potassium bicarbonate 905 MG / sodium bicarbonate 2110 MG per 118 ML) Oral SuspensionSY1
1538294Fast Heartburn Relief OTC 545 MG / 905 MG / 2110 MG per 118 ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
POTASSIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69016-001-182019-11-27C16284748780-19855e2a2-4cf2-60a7-e053-dbdaa90a05bdRelief OTC Antacid
69016-001-542019-11-27C16284748780-19855e2a2-4cf2-60a7-e053-dbdaa90a05bdRelief OTC Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69016-001-18Relief OTC antacid118 mL in 1 BOTTLELIQUID1181
69016-001-54Relief OTC antacid354 mL in 1 BOTTLELIQUID3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69016-001RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]1Legacy NDC, 2 package rows20140529_3b876d55-f199-44cf-8963-7e895b3f5837.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK1
POTASSIUM BICARBONATEACTIVE INGREDIENTHM5Z15LEBN1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
POTASSIUM CATIONACTIVE MOIETY295O53K1521
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004S1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69016-00169016-001-18, 69016-001-54

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 175 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / VAGINAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MAGNESIUM HYDROXIDEMAGNESIUM HYDROXIDENBZ3QY004SCAPSULE, DELAYED RELEASE / ORAL6.7 mgExact identifier — unii candidate
6 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY, METERED / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, CHEWABLE / ORAL0.14 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / PARENTERAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRA-ARTICULAR0.03 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
MAGNESIUM HYDROXIDEMAGNESIUM HYDROXIDENBZ3QY004STABLET, FILM COATED / ORAL43.4 mgExact identifier — unii candidate
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
MAGNESIUM HYDROXIDEMAGNESIUM HYDROXIDENBZ3QY004SPOWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii candidate
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IRRIGATION2 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER / ORALNAExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / PARENTERAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e6cff231-ba97-4016-ab47-323461fb6d703b876d55-f199-44cf-8963-7e895b3f58372014-05-29WarningsExact identifier
spl id: e6cff231-ba97-4016-ab47-323461fb6d70
spl set id: 3b876d55-f199-44cf-8963-7e895b3f5837

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.