Tagamet Tablet
FDA Label NDC 52183-223

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Tagamet (NDC 52183-223). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Cimetidine 200mg

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 foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to cimetidine 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

  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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
  • kidney disease
  • liver 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

  • you need to take this product for more than 14 days
  • stomach pain continues
  • your heartburn continues or worsens

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 (1-800-222-1222) right away.

Directions

  • adults and children 12 years and older:
    ▪ to relieve symptoms, swallow 1 tablet with a glass of water
    ▪ to prevent symptoms, swallow 1 tablet with a glass of water right before or any time up to 30 minutes before eating food or drinking beverages that cause heartburn
    ▪ do not take more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information

store at 15-30°C (59-86°F)

Inactive Ingredients

cellulose, corn starch, FD&C Blue #1 Lake, flavor, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Questions?

Call toll-free 1-800-482-4394 weekdays

Principal Display Panel

Tagamet® HB 200
Cimetidine Tablets 200 mg
Acid Reducer

30 tablets (30 doses)

Principal Display Paneltagamet® Hb 200cimetidine Tablets 200 mgacid Reducericy Cool Mint Flavor 30 Tablets (30 Doses) (Tagamet Mint 01)

Principal Display Paneltagamet® Hb 200cimetidine Tablets 200 mgacid Reducericy Cool Mint Flavor 30 Tablets (30 Doses) (Tagamet Mint 01)

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