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- NDC Code(s): 41250-712-02, 41250-712-71, 41250-712-78
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 11, 2022
If you are a consumer or patient please visit this version.
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- Active ingredient (in each tablet)
Famotidine 20 mg
- Purpose
Acid reducer
- 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 beverages
- 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 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)
- Directions
- •
- adults and children 12 years and over:
- •
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- •
- to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutesbefore eating food or drinking beverages that cause heartburn
- •
- do not use more than 2 tablets in 24 hours
- •
- children under 12 years: ask a doctor
- 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
- Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide
- Questions or comments?
1-800-719-9260
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- INGREDIENTS AND APPEARANCE
HEARTBURN RELIEF
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-712 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 20mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code L194 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-712-02 25 in 1 CARTON 04/17/2019 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41250-712-71 1 in 1 CARTON 04/17/2019 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:41250-712-78 2 in 1 CARTON 08/11/2022 3 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077351 04/17/2019 Labeler -Meijer Distribution Inc(006959555)
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Safety
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More Info on this Drug
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View Labeling Archives for this drug
HEARTBURN RELIEF- famotidine tablet, film coated
Number of versions: 4
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Aug 17, 2022 | 5 (current) | download |
| Jul 22, 2021 | 4 | download |
| Jun 2, 2020 | 3 | download |
| Apr 18, 2019 | 2 | download |
RxNorm
HEARTBURN RELIEF- famotidine tablet, film coated
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 310273 | famotidine 20 MG Oral Tablet | PSN |
| 2 | 310273 | famotidine 20 MG Oral Tablet | SCD |
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HEARTBURN RELIEF- famotidine tablet, film coated
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NDC Codes
HEARTBURN RELIEF- famotidine tablet, film coated
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 41250-712-02 |
| 2 | 41250-712-71 |
| 3 | 41250-712-78 |
