Drug Facts

Composition & Product

Active Ingredients

Ranitidine (150 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Hypromelloses Ferric Oxide Red Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycols Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 9R Shape: oval Color: pink Size: 12 mm Score: 1

Marketing Status

ANDA Active Since 2012-03-30

Medication Information

Purpose

Acid reducer

Description

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

Uses

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

Warnings

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

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
if you have kidney disease, except under the advice and supervision of a doctor

Questions?

Call 1-800-406-7984

Other Information

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
store at 20° - 25° C (68° - 77° F)
avoid excessive heat or humidity
this product is sodium and sugar free

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Principal Display Panel

Premier Value ^®

NDC 68016-351-24

^† Compare to the active ingredient of Zantac 150 ^®

Maximum Strength

Ranitidine Tablets, USP 150 mg

Acid Reducer

Prevents & Relieves Heartburn Associated With Acid Indigestion & Sour Stomach

24 Tablets

DISTRIBUTED BY CHAIN DRUG CONSORTIUM

5097265/ R0712

Stop Use and Ask A Doctor If

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

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

Active Ingredient (in Each Tablet)

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

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

Structured Label Content

Uses (USES)

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

Purpose (PURPOSE)

Acid reducer

Warnings (WARNINGS)

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Directions (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

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
if you have kidney disease, except under the advice and supervision of a doctor

Questions? (QUESTIONS?)

Call 1-800-406-7984

Other Information (OTHER INFORMATION)

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
store at 20° - 25° C (68° - 77° F)
avoid excessive heat or humidity
this product is sodium and sugar free

Inactive Ingredients (INACTIVE INGREDIENTS)

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Premier Value ^®

NDC 68016-351-24

^† Compare to the active ingredient of Zantac 150 ^®

Maximum Strength

Ranitidine Tablets, USP 150 mg

Acid Reducer

Prevents & Relieves Heartburn Associated With Acid Indigestion & Sour Stomach

24 Tablets

DISTRIBUTED BY CHAIN DRUG CONSORTIUM

5097265/ R0712

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"USES": "relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages", "PURPOSE": "Acid reducer", "WARNINGS": "Allergy alert: Do not use if you are allergic to ranitidine 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 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", "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 if you have kidney disease, except under the advice and supervision of a doctor", "QUESTIONS?": "Call 1-800-406-7984", "OTHER INFORMATION": "TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. store at 20° - 25° C (68° - 77° F) avoid excessive heat or humidity this product is sodium and sugar free", "INACTIVE INGREDIENTS": "Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "Premier Value ® NDC 68016-351-24 † Compare to the active ingredient of Zantac 150 ® Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Prevents & Relieves Heartburn Associated With Acid Indigestion & Sour Stomach 24 Tablets DISTRIBUTED BY CHAIN DRUG CONSORTIUM 5097265 / R0712", "Stop use and ask a doctor if": "your heartburn continues or worsens you need to take this product for more than 14 days", "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 right away (1-800-222-1222).", "ACTIVE INGREDIENT (IN EACH TABLET)": "Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information