DailyMed - DG HEALTH HEARTBURN PREVENTION- famotidine tablet, film coated

NDC Code(s): 59368-279-01, 59368-279-02, 59368-279-03
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 ingredient (in each tablet)
Famotidine 20 mg

Famotidine 20 mg
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Purpose
Acid reducer

Acid reducer
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Uses
relieves heartburn associated with acid indigestion and sour stomach - prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and ...
- relieves heartburn associated with acid indigestion and sour stomach
- prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
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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. 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: to - relievesymptoms, swallow 1 tablet with a glass of water. Do not chew. to - preventsymptoms, swallow 1 tablet with a glass of water at any ...
- adults and children 12 years and over:
- to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
- to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60minutes beforeeating food or drinking beverages that cause heartburn
- do not use more than 2 tablets in 24 hours
- children under 12 years: ask a doctor
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Other information
read the directions and warnings before use - keep the carton. It contains important information. store at 20°-25°C (68°-77°F) protect from moisture
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20°-25°C (68°-77°F)
- protect from moisture
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Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium ...

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
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Questions or comments?
1-888-309-9030

1-888-309-9030
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Principal Display Panel
SEE NEW WARNINGS - Compare to the active ingredient of Maximum Strength Pepcid - ®AC - Maximum Strength - Heartburn Prevention - Famotidine Tablets, 20 mg - Acid Reducer - Just One Tablet Prevents ...

SEE NEW WARNINGS

Compare to the active ingredient of Maximum Strength Pepcid ®AC

Maximum Strength

Heartburn Prevention

Famotidine Tablets, 20 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

200 Tablets

Actual Tablet Size

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Praxis, LLC		016329513	manufacture(59368-279) , label(59368-279) , pack(59368-279)

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	RxCUI	RxNorm NAME	RxTTY
1	310273	famotidine 20 MG Oral Tablet	PSN
2	310273	famotidine 20 MG Oral Tablet	SCD

Label: DG HEALTH HEARTBURN PREVENTION- famotidine tablet, film coated

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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

	NDC
1	59368-279-01
2	59368-279-02
3	59368-279-03

Label: DG HEALTH HEARTBURN PREVENTION- famotidine tablet, film coated

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

DG HEALTH HEARTBURN PREVENTION- famotidine tablet, film coated

Number of versions: 1

DG HEALTH HEARTBURN PREVENTION- famotidine tablet, film coated

DG HEALTH HEARTBURN PREVENTION- famotidine tablet, film coated

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DG HEALTH HEARTBURN PREVENTION- famotidine tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.