DailyMed - INJOY HEARTBURN RELIEF- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

NDC Code(s): 59368-298-01
Packager: Praxis, LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 1, 2023

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Active ingredients (in each chewable tablet)
Famotidine 10 mg - Calcium carbonate 800 mg - Magnesium hydroxide 165 mg

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg
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Purposes
Acid reducer - Antacid

Acid reducer

Antacid
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Use
relieves heartburn associated with acid indigestion and sour stomach

relieves heartburn associated with acid indigestion and sour stomach
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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 ...
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 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

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)

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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 ...
- 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
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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 ...
- 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
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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 ...

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
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Questions or comments?
1-800-864-9649

1-800-864-9649
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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 ...

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

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INGREDIENTS AND APPEARANCE

Product Information

INJOY HEARTBURN RELIEF famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59368-298
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	800 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	165 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ASPARTAME (UNII: Z0H242BBR1)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
DEXTRATES (UNII: G263MI44RU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	pink (mottled)	Score	no score
Shape	ROUND (bi-layered)	Size	17mm
Flavor	BERRY	Imprint Code	L321
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59368-298-01	1 in 1 CARTON	08/09/2022
1		25 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077355	08/09/2022

Labeler - Praxis, LLC (016329513)

Name	Address	ID/FEI	Business Operations
Establishment
Praxis, LLC		016329513	manufacture(59368-298) , label(59368-298) , pack(59368-298)

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	RxCUI	RxNorm NAME	RxTTY
1	283641	famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable Tablet	PSN
2	283641	calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet	SCD
3	283641	calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet	SY

Label: INJOY HEARTBURN RELIEF- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: INJOY HEARTBURN RELIEF- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

INJOY HEARTBURN RELIEF- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

Number of versions: 1

INJOY HEARTBURN RELIEF- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

INJOY HEARTBURN RELIEF- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

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INJOY HEARTBURN RELIEF- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

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