FDA.reportPublic FDA data

injoy heartburn relief

Manufacturer
Sixarp, LLC
Effective date
2025-09-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:14:11

Label at a glance#

Productinjoy heartburn relief
Active ingredientFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE
Label structure9 sections

Dosage and administration

adults and children 12 years and over: do not swallow tablet whole: chew completely to relieve symptoms, chew 1 tablet before swallowing do not use more than 2 chewable tablets in 24 hours children under 12 years: ask a doctor

Storage and handling

each tablet contains: calcium 330 mg; magnesium 80 mg Phenylketonurics: Contains Phenylalanine 2 mg per tablet read the directions and warnings before use read the bottle label. It contains important information. store at 20-25 ° C (68-77 ° F) protect from moisture

Label contents#

Full prescribing information#

Active ingredients (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purposes

OTC - PURPOSE SECTION

Acid reducer

Antacid

Use

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • with other acid reducers

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating, or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over:
  • do not swallow tablet whole: chew completely
  • to relieve symptoms, chew1 tablet before swallowing
  • do not use more than 2 chewable tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains:calcium 330 mg; magnesium 80 mg
  • Phenylketonurics: Contains Phenylalanine 2 mg per tablet
  • read the directions and warnings before use
  • read the bottle label. It contains important information.
  • store at 20-25 °C (68-77 °F)
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Questions or comments?

OTC - QUESTIONS SECTION

1-800-864-9649

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEE NEW WARNINGS

PERRIGO SelfCare ™

injoy

Heartburn Relief

Famotidine 10 mg, Calcium Carbonate 800 mg, Magnesium Hydroxide 165 mg Tablets (Chewable)

Acid Reducer + Antacid

Dual Action

Just one tablet!

Relieves heartburn due to acid indigestion

Berry Flavor

25 CHEWABLE TABLETS

ACTUAL SIZE

cartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
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fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59368-29859368-298-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS LACTOSE3SY5LH9PMKIACT
ASPARTAMEZ0H242BBR1IACT
D&C RED NO. 7ECW0LZ41X8IACT
DEXTRATESG263MI44RUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TALC7SEV7J4R1UIACT
FAMOTIDINE5QZO15J2Z8ACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB

Source Document#

Source XML

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
42246cb9-0bc2-3906-e063-6294a90a82a82faff171-575b-3fd8-e063-6294a90a2bce2025-10-27WarningsExact identifier
spl set id: 2faff171-575b-3fd8-e063-6294a90a2bce

Reported adverse events (FAERS/openFDA)#

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