Drug Facts

Composition & Product

Active Ingredients

Ranitidine (75 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Hypromelloses Ferric Oxide Red Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: OR;606 Shape: round Color: pink Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2012-07-10

Medication Information

Purpose

Acid reducer

Description

Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 mg)

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 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

Questions?

call 1-800-406-7984

Read the directions, consumer information leaflet and warnings before use.

Keep the carton. It contains important information.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

Other Information

•
TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP 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 400, talc, titanium dioxide

Principal Display Panel

Premier Value ^®

NDC 68016-352-60

Ranitidine Tablets, USP 75 mg

Acid Reducer

Regular Strength

60 Tablets

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

^† Compare to the active ingredient of Zantac 75 ^®

^† This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals Inc., owner of the registered trademark Zantac 75 ^® .

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 75 mg (as ranitidine hydrochloride USP, 84 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 eating or drinking 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

Questions? (QUESTIONS?)

call 1-800-406-7984

Read the directions, consumer information leaflet and warnings before use.

Keep the carton. It contains important information.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

Other Information (OTHER INFORMATION)

•
TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP 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 400, talc, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Premier Value ^®

NDC 68016-352-60

Ranitidine Tablets, USP 75 mg

Acid Reducer

Regular Strength

60 Tablets

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

^† Compare to the active ingredient of Zantac 75 ^®

^† This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals Inc., owner of the registered trademark Zantac 75 ^® .

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 75 mg (as ranitidine hydrochloride USP, 84 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 eating or drinking 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", "QUESTIONS?": "call 1-800-406-7984 Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information. DISTRIBUTED BY CHAIN DRUG CONSORTIUM 3301 NW BOCA RATON BLVD SUITE 101, BOCA RATON, FL 33431", "OTHER INFORMATION": "• TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP 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 400, talc, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "Premier Value ® NDC 68016-352-60 Ranitidine Tablets, USP 75 mg Acid Reducer Regular Strength 60 Tablets Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach † Compare to the active ingredient of Zantac 75 ® † This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals Inc., owner of the registered trademark Zantac 75 ® .", "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 75 mg (as ranitidine hydrochloride USP, 84 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