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injoy heartburn relief

Injoy Heartburn Relief Drug Facts

Approved
Approval ID

2faff171-575b-3fd8-e063-6294a90a2bce

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 18, 2025

Manufacturers
FDA

Sixarp, LLC

DUNS: 016329513

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

famotidine, calcium carbonate and magnesium hydroxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59368-298
Application NumberANDA077355
Product Classification
M
Marketing Category
C73584
G
Generic Name
famotidine, calcium carbonate and magnesium hydroxide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2025
FDA Product Classification

INGREDIENTS (16)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FAMOTIDINEActive
Quantity: 10 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 800 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
MAGNESIUM HYDROXIDEActive
Quantity: 165 mg in 1 1
Code: NBZ3QY004S
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/7/2022

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

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/7/2022

Use

relieves heartburn associated with acid indigestion and sour stomach

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/7/2022

Active ingredients (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/7/2022

Purposes

Acid reducer

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 9/7/2022

Warnings

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

Do not use

  • 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

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • heartburn withlightheadedness, sweating, or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequentchest 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

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

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/7/2022

Directions

  • 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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/7/2022

Other information

***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 INGREDIENT SECTION

LOINC: 51727-6Updated: 9/7/2022

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/7/2022

Questions or comments?

1-800-864-9649

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