Tagamet

Tagamet
SPL v9
SPL
SPL Set ID e6401e0a-8612-42e8-bf89-2d67243f28dc
Route
ORAL
Published
Effective Date 2024-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cimetidine (200 mg)
Inactive Ingredients
Starch, Corn Hypromelloses Magnesium Stearate Polyethylene Glycol, Unspecified Polysorbate 80 Povidone Sodium Lauryl Sulfate Sodium Starch Glycolate Type A Potato Titanium Dioxide Microcrystalline Cellulose Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: TAGAMET;200 Shape: diamond Color: white Color: blue Size: 13 mm Score: 2
Marketing Status
NDA Active Since 2023-02-01

Description

Drug Facts

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Drug Facts

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
Section 42229-5

Drug Facts

Warnings

Allergy a lert: Do not use if you are allergic to cimetidine or other acid reducers.

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 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
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
Questions?

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

tagamet.com

Other Information

store at 15-30ºC (59-86ºF)

Inactive Ingredients

cellulose, corn starch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Principal Display Panel

Tagamet® HB 200

Cimetidine Tablets 200 mg

Acid Reducer

70 tablets (70 doses)



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.

Active Ingredient (in Each Tablet)

Cimetidine 200mg

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.


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Acid reducer

Warnings

Allergy a lert: Do not use if you are allergic to cimetidine or other acid reducers.

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 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
Do Not Use (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
Questions?

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

tagamet.com

Other Information (Other information)

store at 15-30ºC (59-86ºF)

Inactive Ingredients (Inactive ingredients)

cellulose, corn starch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Tagamet® HB 200

Cimetidine Tablets 200 mg

Acid Reducer

70 tablets (70 doses)



Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Cimetidine 200mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if)

you are taking  a prescription drug.

Acid reducers may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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