Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 12a38e29-130c-6d41-1753-acccb0b41efe
Route
ORAL
Published
Effective Date 2019-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ranitidine (75 mg)
Inactive Ingredients
Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Ferrosoferric Oxide Titanium Dioxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2000-03-01

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
Section 50565-1

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).

Section 51945-4

Ranitidine Tablets USP, 75 mg - container label

Section 53413-1

Questions? call 1-888-375-3784

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information .

Section 53414-9

If pregnant or breast-feeding , ask a health professional before use.

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)
    • do not chew tablet
  • 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

  • this product is sodium and sugar free
  • Blister: do not use if individual blister unit is open or torn

    Bottle: do not use if printed foil under bottle cap is open or torn
  • avoid excessive heat or humidity
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Stop Use and Ask A Doctor If

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Active Ingredient (in Each Tablet)

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

Ask A Doctor Before Use If You Have

  • 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
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease
Ask A Doctor Or Pharmacist Before Use If You Are

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.


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 eating or drinking certain foods and beverages
Section 50565-1 (50565-1)

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).

Section 51945-4 (51945-4)

Ranitidine Tablets USP, 75 mg - container label

Section 53413-1 (53413-1)

Questions? call 1-888-375-3784

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information .

Section 53414-9 (53414-9)

If pregnant or breast-feeding , ask a health professional before use.

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)
    • do not chew tablet
  • 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)

  • this product is sodium and sugar free
  • Blister: do not use if individual blister unit is open or torn

    Bottle: do not use if printed foil under bottle cap is open or torn
  • avoid excessive heat or humidity
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

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
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)

  • 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
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)