Family Wellness

Family Wellness
SPL v1
SPL
SPL Set ID 3cff4f08-e8e4-4324-a08b-9970c25665c4
Route
ORAL
Published
Effective Date 2014-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ranitidine (75 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromelloses Ferric Oxide Red Magnesium Stearate Talc Titanium Dioxide Polyethylene Glycol 400 Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: OR;606 Shape: round Color: pink Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2013-09-24

Description

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

Purpose

Acid reducer


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 certain foods and beverages 
Warnings

Allergy alert: Do not use if you are allergic to ranitidine or any 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
Other Information
  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
  • store at 20º-25ºC (68º-77ºF)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hyrpomellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide 

Questions Or Comments?

Call 1-800-406-7984

Principal Display Panel

FAMILY

wellness

COMPARE TO THE ACTIVE INGREDIENT OF ZANTAC 75® TABLETS*

Regular Strength

Acid Reducer

Ranitidine Tablets USP, 75 mg

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

30 TABLETS

MADE IN INDIA

DISTRIBUTED BY

FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD,

MATTHEWS, NC 28105 USA

5110364 0614

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

 

Family Wellness

Family Wellness

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 (1-800-222-1222) right away. 

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
  • 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 any 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 (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
Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
  • store at 20º-25ºC (68º-77ºF)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hyrpomellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide 

Questions Or Comments? (Questions or comments?)

Call 1-800-406-7984

Principal Display Panel (Principal display panel)

FAMILY

wellness

COMPARE TO THE ACTIVE INGREDIENT OF ZANTAC 75® TABLETS*

Regular Strength

Acid Reducer

Ranitidine Tablets USP, 75 mg

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

30 TABLETS

MADE IN INDIA

DISTRIBUTED BY

FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD,

MATTHEWS, NC 28105 USA

5110364 0614

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

 

Family Wellness

Family Wellness

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 (1-800-222-1222) right away. 

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


Raw Label Data

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