Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 00df8a42-296f-80dd-98af-ee8b30eb38cc
Route
ORAL
Published
Effective Date 2020-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ranitidine (150 mg)
Inactive Ingredients
Fd&c Red No. 40 Hypromellose 2910 (6 Mpa.s) Ferrosoferric Oxide Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Titanium Dioxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2009-12-02

Description

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

Use(s)

  • 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 42229-5

Tips for managing heartburn

  • Do not lie flat or bend over soon after eating
  • Do not eat late at night, or just before bedtime

  • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, and even some fruits and vegetables.

  • Eat slowly and do not eat beig meals

  • If you are overweight, lose weight

  • If you smoke, quit smoking

  • Raise the head of your bed

  • Wear loose fitting clothing around your stomach.

Revised: 03/20

Section 51945-4

Container Carton Label:

Dr.Reddy's

NDC 55111-404-34



Compare to the active

ingredient in Zantact 150® Tablets*



Maximum Strength

Ranitidine

Tablets USP,150 mg

ACID REDUCER



PREVENTS & RELIEVES

heartburn associated with acid indigestion

and sour stomach

24 Tablets(24 doses)



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 1-888-375-3784

Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

Other Information

  • do not use if printed foil under bottle cap is open or torn
  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat or humidity
  • protect from light
  • this product is sodium and sugar free
Inactive Ingredients

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

Stop Use and Ask 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 150 mg (as ranitidine hydrochloride USP, 168 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
Package Label Principal Display Panel

Container Label:

Dr.Reddy's

NDC 55111-404-34



Maximum Strength

Ranitidine

Tablets USP,150 mg

ACID REDUCER



PREVENTS & RELIEVES

HEARTBURN associated with acid indigestion

and sour stomach

24 Tablets(24 doses)

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

Use(s)

  • 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 42229-5 (42229-5)

Tips for managing heartburn

  • Do not lie flat or bend over soon after eating
  • Do not eat late at night, or just before bedtime

  • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, and even some fruits and vegetables.

  • Eat slowly and do not eat beig meals

  • If you are overweight, lose weight

  • If you smoke, quit smoking

  • Raise the head of your bed

  • Wear loose fitting clothing around your stomach.

Revised: 03/20

Section 51945-4 (51945-4)

Container Carton Label:

Dr.Reddy's

NDC 55111-404-34



Compare to the active

ingredient in Zantact 150® Tablets*



Maximum Strength

Ranitidine

Tablets USP,150 mg

ACID REDUCER



PREVENTS & RELIEVES

heartburn associated with acid indigestion

and sour stomach

24 Tablets(24 doses)



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 (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 1-888-375-3784

Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

Other Information (Other information)

  • do not use if printed foil under bottle cap is open or torn
  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat or humidity
  • protect from light
  • this product is sodium and sugar free
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 Doctor If (Stop use and ask 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 150 mg (as ranitidine hydrochloride USP, 168 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
Package Label Principal Display Panel (PACKAGE LABEL PRINCIPAL DISPLAY PANEL)

Container Label:

Dr.Reddy's

NDC 55111-404-34



Maximum Strength

Ranitidine

Tablets USP,150 mg

ACID REDUCER



PREVENTS & RELIEVES

HEARTBURN associated with acid indigestion

and sour stomach

24 Tablets(24 doses)

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

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