Major Heartburn Relief Maximum Strength

• 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

• 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 minutes before 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

• 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 and light

Applies to famotidine: oral powder for suspension, oral tablet, oral tablet chewable, oral tablet disintegrating

Along with its needed effects, famotidine (the active ingredient contained in Heartburn Relief Maximum Strength) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking famotidine:

• Bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• bloody, black, or tarry stools
• chest pain
• chills
• cough or hoarseness
• diarrhea
• fever
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• itching
• joint or muscle pain
• lower back or side pain
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• red, irritated eyes
• red skin lesions, often with a purple center
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

• Abdominal or stomach pain
• anxiety
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• clay-colored stools
• dark urine
• depression
• difficulty with breathing
• difficulty with swallowing
• dizziness
• dry mouth
• fainting
• false sense of well-being
• fast, irregular, pounding, or racing heartbeat or pulse
• headache
• hives
• hyperventilation
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• loss of bladder control
• loss of consciousness
• mood swings
• nausea
• nervousness
• noisy breathing
• personality changes
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• restlessness
• seizures
• shaking
• skin rash
• swelling around the eyes
• tightness in the chest
• total body jerking
• trouble with sleeping
• troubled with breathing
• unpleasant breath odor
• vision changes
• vomiting of blood
• wheezing
• yellow eyes or skin

Some side effects of famotidine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty having a bowel movement (stool)

• Swelling of the breasts or breast soreness in both females and males

• Abdominal or stomach discomfort
• blemishes on the skin
• change in taste or bad, unusual or unpleasant (after) taste
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased interest in sexual intercourse
• difficulty with moving
• dry skin
• fear
• hair loss or thinning of the hair
• hearing loss
• hives or welts
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• mood or mental changes
• muscle cramps
• muscle stiffness
• pimples
• redness of the skin
• redness of the white part of the eyes
• seeing, hearing, or feeling things that are not there
• sleeplessness
• unable to sleep
• weight loss

Applies to famotidine: compounding powder, intravenous solution, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet disintegrating

General

The most commonly reported side effects include headache, dizziness, constipation, and diarrhea.[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea
Uncommon (0.1% to 1%): Nausea, vomiting, flatulence, dry mouth, abdominal discomfort or distension[Ref]

Nervous system

Convulsions occurred in patients with renal dysfunction.[Ref]

Common (1% to 10%): Headache, dizziness
Very rare (less than 0.01%): Paresthesia, somnolence, epileptic seizures, convulsion
Frequency not reported: Grand mal seizure, taste disorder[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus
Rare (0.01% to 0.1%): Urticaria, angioneurotic edema
Very rare (less than 0.01%): Alopecia, severe skin reactions, toxic epidermal necrolysis, Stevens-Johnson syndrome, epidermal necrolysis
Frequency not reported: Acne, dry skin, flushing[Ref]

Other

Uncommon (0.1% to 1%): Fatigue
Frequency not reported: Asthenia, fatigue, facial/orbital edema, tinnitus[Ref]

Metabolic

Uncommon (0.1% to 1%): Loss of appetite
Frequency not reported: Anorexia[Ref]

Hematologic

Rare (0.01% to 0.1%): Thrombocytopenia, leukopenia, agranulocytosis, pancytopenia
Frequency not reported: Neutropenia[Ref]

Hepatic

Rare (0.01% to 0.1%): Intrahepatic cholestasis, jaundice, increased liver enzyme abnormalities (transaminases, gamma GT, alkaline phosphatase, bilirubin)
Frequency not reported: Cholestatic jaundice, hepatitis[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity reactions, anaphylaxis[Ref]

Respiratory

Rare (0.01% to 0.1%): Bronchospasm
Frequency not reported: Interstitial pneumonia[Ref]

Musculoskeletal

Rare (0.01% to 0.1%): Arthralgia
Very rare (less than 0.01%): Muscle cramps
Frequency not reported: Rhabdomyolysis, musculoskeletal pain[Ref]

Psychiatric

When patients obtained follow-up, psychic disturbances were found to be reversible.[Ref]

Very rare (less than 0.01%): Hallucinations, disorientation, confusion, anxiety, agitation, depression, reduced libido, insomnia
Frequency not reported: Psychic disturbances[Ref]

Cardiovascular

QT interval prolongation occurred in patients with renal dysfunction.[Ref]

Very rare (less than 0.01%): Chest tightness, prolonged QT interval
Frequency not reported: Arrhythmia, atrioventricular block, palpitation[Ref]

Genitourinary

Very rare (less than 0.01%): Impotence[Ref]

Ocular

Frequency not reported: Conjunctival injection[Ref]

Endocrine

Frequency not reported: Gynecomastia[Ref]

Some side effects of Heartburn Relief Maximum Strength may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.