tagamet - accessdata.fda.gov · cimetidine 200 mg.....acid reducer uses • relieves heartburn...

Just ON

E TABLET RELIEV

ESa

nd PREV

ENTS H

eartb

urna

nd A

cid Ind

igestion

42037 103710 2

Tamper Evident: Each tablet

individually sealed in a blister pack. Do not use ifblister or foil is open or torn.

before meal•during meal•after meal TAKE ANYTIME YOU NEED IT:

RELIEVES and PREVENTS Heartburn and Acid Indigestion

JUSTONE TABLET

6 TABLETS (6 DOSES)

Actual size

Dist. by Medtech Products Inc. Tarrytow

n, NY 10591 A Prestige Consum

er Healthcare company

©2018 Trade dress is ow

ned by Medtech Products Inc.

All rights reserved. M

ade in Spain. TGUS004101

Read and retain the important information and drug interaction warnings printed on the inside of this carton

TagametTagamet®®

200HBHB

Tagamet Tagamet®®

200HBHB

Tagamet

Tagamet

®®

200H

BH

B

Tagamet

Tagamet

®®

200 H

BH

B

Cimetidine Tablets 200 mgAcid Reducer

Cimetidine Tablets 200 mg Acid Reducer

Drug Facts Active ingredient (in each tablet) Purpose Cimetidine 200 mg....................................................................................................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 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

Other information store at 15°-30°C (59°-86°F)

Inactive ingredients cellulose, corn starch, 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 tagamet.com

READ THE DIRECTIONS AND WARNINGS, INCLUDING THOSE PRINTED ON THE INSIDE OF THE CARTON, BEFORE TAKING THIS PRODUCT.

10629-01-17

Reference ID: 4407872

Drug Interaction Warnings:

Tagamet HB 200

® affects some prescription m

edicines causing slightly higher levels of those medicines in

the blood. Higher blood levels could lead to side effects in rare situations. If you currently take Theophylline (oral asthm

a medicine), W

arfarin (blood thinning medicine) or Phenytoin (seizure m

edicine), consult your doctor before taking Tagam

et HB 200®

.Brand nam

es of some m

edicines which contain one of these ingredients include:

There may be other m

edicinesthat

contain one

of these

ingredients. If in doubt about this or about possible effects of Tagam

et HB 200® on any other

medicines you are taking, talk

to your doctor or pharmacist.

Read the directions and warnings before taking this m

edication.Q

uestions? 1-800-482-4394

Tips for Managing Heartburn

• Do not lie flat or bend over soon after eating • Do not eat late at night, or just before bedtim

e • Certain foods or drinks are m

ore likely to causeheartburn, such as rich, spicy, fatty, and friedfoods, chocolate, caffeine, alcohol, even som

e fruits and vegetables

• Eat slowly and do not eat big m

eals• If you are overw

eight, lose weight

• If you smoke, quit sm

oking• Raise the head of your bed• W

ear loose fitting clothing around your stomach

In clinical studies, Tagamet HB 200

® w

as significantly better thanplacebo tablets in relieving and preventing heartburn sym

ptoms.

Percent of Patients with Prevention

or Reduction of Heartburn Symptom

sW

hen Taken at Time of M

eal

Study E

53%

38%

41%

30%

Study F

Study C

S

tudy D

56%

82%

53%

Percent of Patients with Prevention or Reduction of Heartburn

Symptom

s When Taken 30 M

inutes Before a Meal

83%

Tagamet H

B 200 Placebo Tablet

Tagamet H


Percent of Heartburn Episodes Relieved

Study A

S

tudy B

67%75%

45%50%

Tagamet H


Tagamet H


Tagamet H


Tagamet H


THEO

PHYLLIN

E TH

EO-D

UR

® Theochron

® Slo-B

id®

U

niphyl ® Theo-24

®

W

ARFA

RIN

Coumadin

®

PHEN

YTOIN

D

ilantin®


Tamper Evident: Each tablet individually sealed in a

blister pack. Do not use if blister or foil is open or torn.






All rights reserved. Made in Spain. TGUS002101

For more inform

ation, visit tagamet.com



JUSTONE TABLET

Actual size

Just ON

E TABLET

RELIEVES a

nd PREV

ENTS

Hea

rtburn a

ndA

cid Ind

igestion


TagametTagamet®®

200HBHB

Tagamet Tagamet®®

200HBHB

Tagamet

Tagamet

®®

200 H

BH

B

Tagamet

Tagamet

®®

200H

BH

B



30 TABLETS (30 DOSES)

Drug Facts Active ingredient (in each tablet) Purpose Cimetidine 200 mg....................................................................................................Acid reducer


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 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





10628-01-17



edication.Q

uestions? 1-800-482-4394








eight, lose weight





Tagamet HB 200




a medicine), W



et HB 200®

.Brand nam

es of some m



edicinesthat

contain one

of these





THEO

PHYLLIN

E TH

EO-D

UR

® Theochron

® Slo-B

id®

U

niphyl ® Theo-24

®

W

ARFA

RIN

Coumadin

®

PHEN

YTOIN

D

ilantin®


® w


ptoms.


Study A

50%

Placebo Tablet

67%

Tagamet H

B 200

Study B

45%

Placebo Tablet


Symptom

s When Taken 30 M


Study C

82%

Tagamet H

B 200

Study D

75%

Tagamet H

B 200



sW


eal

Study E

53%

38%

41%

30%

Study F

Tagamet H


Tagamet H


83%

Tagamet H

B 200

56%

Placebo Tablet

53%

Placebo Tablet







All rights reserved. Made in Spain.

TGUS009101

Just ON

E TABLET RELIEV

ESa

nd PREV

ENTS H

eartb

urna

nd A

cid Ind

igestion

Tamper Evident: Each tablet individually sealed in a

blister pack. Do not use if blister or foil is open or torn.

Just ON

E TABLET RELIEV

ESa

nd PREV

ENTS H

eartb

urna

nd A

cid Ind

igestion



JUSTONE TABLET

50 TABLETS (50 DOSES)

Actual size


TagametTagamet®®

200HBHB

Tagamet Tagamet®®

200HBHB

Tagamet

Tagamet

®®

200 H

BH

B

Tagamet

Tagamet

®®

200 H

BH

B



Drug Facts Active ingredient (in each tablet) Purpose Cimetidine 200 mg......................................................................................Acid reducer


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 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





PRINTED OR DEBOSSED ONLINE:

XXXXXXX MM/YYYY

10667-01-17

CPC Item # 4759/50BB



edication.Q

uestions? 1-800-482-4394








eight, lose weight





® w


ptoms.



sW


eal

Study E

53%

38%

41%

30%

Study F

Study C

S

tudy D

56%

82%

53%


Symptom

s When Taken 30 M


83%

Tagamet H


Tagamet H



Study A

S

tudy B67%

75%

45%50%

Tagamet H


Tagamet H


Tagamet H


Tagamet H



Tagamet HB 200




a medicine), W



et HB 200®

.Brand nam

es of some m



edicinesthat

contain one

of these





THEO

PHYLLIN

E TH

EO-D

UR

® Theochron

® Slo-B

id®

U

niphyl ® Theo-24

®

W

ARFA

RIN

Coumadin

®

PHEN

YTOIN

D

ilantin®


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tagamet - accessdata.fda.gov · cimetidine 200 mg.....acid reducer uses • relieves heartburn...

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