Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 70bc7062-ab3c-43eb-b524-0d8c6d1a674d
Route
ORAL
Published
Effective Date 2014-12-10
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 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 2012-08-02

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 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?

or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

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 400, talc, titanium dioxide

Principal Display Panel

Compare to the active ingredient in Zantac75®

WinCo FOODS

REGULAR STRENGTH

Acid Reducer

RANITIDINE TABLETS, USP 75 mg/ ACID REDUCER

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

30 Tablets

DISTRIBUTED BY: WinCo FOODS, LLC, BOISE, ID 83704

5113307/0914

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?)

or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

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 400, talc, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredient in Zantac75®

WinCo FOODS

REGULAR STRENGTH

Acid Reducer

RANITIDINE TABLETS, USP 75 mg/ ACID REDUCER

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

30 Tablets

DISTRIBUTED BY: WinCo FOODS, LLC, BOISE, ID 83704

5113307/0914

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


Raw Label Data

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