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

Purpose

Acid reducer

Description

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


Medication Information

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Active Ingredient

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

Purpose

Acid reducer

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
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.

Description

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

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.

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)



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
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).

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

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Active Ingredient (Active ingredient (in each tablet))

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

Purpose

Acid reducer

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
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.

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.

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)



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
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).

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.


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