Drug Facts

Composition & Product

Active Ingredients

Ranitidine (75 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2013-09-01

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

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

freds ^®

Ranitidine Tablets, USP 75 mg

Acid Reducer

Regular Strength

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

30 Tablets

^† Compare to Active Ingredient of Zantac 75 ^®

DISTRIBUTED BY: fred's, Inc.

5102619/0513

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

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)

freds ^®

Ranitidine Tablets, USP 75 mg

Acid Reducer

Regular Strength

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

30 Tablets

^† Compare to Active Ingredient of Zantac 75 ^®

DISTRIBUTED BY: fred's, Inc.

5102619/0513

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", "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": "freds ® Ranitidine Tablets, USP 75 mg Acid Reducer Regular Strength Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach 30 Tablets † Compare to Active Ingredient of Zantac 75 ® DISTRIBUTED BY: fred's, Inc. 5102619/0513", "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