Acid Relief

Name: Acid Relief

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 foods and beverages

Directions

  • adults and children 12 years and over:
  • to relieve symptoms, swallow 1 tablet with a glass of water
  • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
  • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
  • children under 12 years: ask a doctor

Other information

  • do not use if printed foil under cap is broken or missing
  • store at 20° - 25°C (68° - 77°F)
  • avoid excessive heat or humidity
  • this product is sugar free

Questions or comments?

1-800-719-9260

Principal Display Panel

Acid Relief

Ranitidine Tablets USP, 75 mg

Acid Reducer

One Tablet Prevents & Relieves

Heartburn Associated with Acid Indigestion & Sour Stomach

# Doses {Replace "#" with number tablets in package}

Compare to Zantac 75® active ingredient

Acid Relief Carton

Acid Relief 
ranitidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-271
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 75 mg
Product Characteristics
Color PINK Score no score
Shape HEXAGON (6 sided) Size 8mm
Flavor Imprint Code W75
Contains     
Packaging
# Item Code Package Description
1 NDC:55312-271-39 1 BOTTLE (BOTTLE) in 1 CARTON
1 30 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076760 05/28/2009
Labeler - Western Family Foods Inc (192166072)
Revised: 07/2009   Western Family Foods Inc

For Healthcare Professionals

Applies to ranitidine: compounding powder, injectable solution, intravenous solution, oral capsule, oral granule effervescent, oral syrup, oral tablet, oral tablet effervescent

General

The most commonly reported side effect for IM administration was injection site pain, and the most commonly reported side effects with IV administration were localized pain and burning.[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Abdominal discomfort/pain, constipation, nausea, vomiting
Very rare (less than 0.01%): Acute pancreatitis, diarrhea[Ref]

Abdominal pain, constipation, and nausea tended to improve with continued treatment.[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hypotension, chest pain, arrhythmia, bradycardia, atrioventricular block, tachycardia, premature ventricular beats
Very rare (less than 0.01%): Asystole, vasculitis[Ref]

Bradycardia, atrioventricular block, tachycardia, and asystole have occurred in H2 receptor antagonists.[Ref]

Psychiatric

Rare (0.01% to 0.1%): Insomnia, reversible mental confusion, agitation, depression, hallucinations
Frequency not reported: Loss of libido[Ref]

Nervous system

Headache may be related to administration of treatment.[Ref]

Rare (0.01% to 0.1%): Dizziness, somnolence, vertigo, reversible involuntary movement disorders
Very rare (less than 0.01%): Headache/severe headache[Ref]

Dermatologic

Rare (0.01% to 0.1%): Urticaria, angioneurotic edema, skin rash
Very rare (less than 0.01%): Erythema multiforme, alopecia[Ref]

Musculoskeletal

Very rare (less than 0.01%): Musculoskeletal symptoms, arthralgia, myalgia[Ref]

Hepatic

Rare (0.01% to 0.1%): Transient and reversible changes in liver function tests, increased ALT levels
Very rare (less than 0.01%): Hepatocellular/hepatocanalicular/mixed hepatitis with/without jaundice[Ref]

Hepatitis with/without jaundice were usually reversible.

ALT levels increased to at least 2 times the pretreatment levels in patients receiving high IV doses for at least 5 days.[Ref]

Other

Rare (0.01% to 0.1%): Fever, malaise
Frequency not reported: Death[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity reactions
Very rare (less than 0.01%): Anaphylactic shock/anaphylaxis[Ref]

Anaphylactic shock occurred after administration of a single dose.[Ref]

Renal

Rare (0.01% to 0.1%): Elevation in serum creatinine
Very rare (less than 0.01%): Acute interstitial nephritis[Ref]

Elevation in serum creatinine was usually slight, and typically normalized with continued treatment.[Ref]

Respiratory

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

Ocular

Rare (0.01% to 0.1%): Reversible blurred vision[Ref]

Hematologic

Very rare (less than 0.01%): Blood count changes, leukopenia, thrombocytopenia, granulocytopenia, agranulocytosis, pancytopenia, marrow hypoplasia/aplasia
Frequency not reported: Aplastic anemia, immune hemolytic anemia/acquired immune hemolytic anemia, eosinophilia[Ref]

Leukopenia, granulocytopenia, and thrombocytopenia were usually reversible.[Ref]

Genitourinary

Very rare (less than 0.01%): Reversible impotence, breast symptoms/conditions, galactorrhea[Ref]

Endocrine

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

Metabolic

Postmarketing reports: Acute porphyria[Ref]

Local

Frequency not reported: Injection site pain, transient localized burning or itching[Ref]

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

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