Ranitidine Tablets

Ranitidine Tablets
SPL v11
SPL
SPL Set ID aab81d9f-397d-49fb-8083-77a1872cc71f
Route
ORAL
Published
Effective Date 2018-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ranitidine (150 mg)
Inactive Ingredients
Acacia Cellulose, Microcrystalline Croscarmellose Sodium Fd&c Blue No. 1 Magnesium Stearate Menthol Polyethylene Glycol Polyvinyl Alcohol Talc Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Pill Appearance
Imprint: 150;G Shape: round Color: blue Color: brown Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2019-06-26

Description

Ranitidine 150 mg

Purpose

Acid reducer 


Medication Information

Purpose

Acid reducer 

Description

Ranitidine 150 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

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 (for cool mint tablets only)



◾ 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

◾ do not use if individual blister unit is open or torn.

◾ do not use if printed foil under bottle cap is open or torn



◾ store at 20 0-25 0​C (68 0​-77 0​F)

◾ avoid excessive heat or humidity



◾ this product is sodium and sugar free

Active Ingredient(s)

Ranitidine 150 mg





Inactive Ingredients

For 150 mg:croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,talcum, titanium dioxide



For 150 mg cool mint:acacia, croscarmellose sodium, FD&C Blue No. 1,magnesium stearate, menthol, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, talcum,

titanium dioxide

Questions Or Comments?

•Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM EST.

This product is not manufactured or distributed by Boehringer Ingelheim ® consumer health care products, distributor of Zantac 150mg and 150mg Cool Mint

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Ask A Doctor Before Use If

◾ 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.

Stop Use and Ask Doctor If

◾ your heartburn continues or worsens

◾ you need to take this product for more than 14 days

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Read the Directions and Warnings Before Use.

Keep the carton. It contains important information including tips for managing heartburn.

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 andfried foods, chocolate, caffeine, alcohol, even some fruits and vegetables.



•Eat slowly and do not eat big 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


Structured Label Content

Use(s) (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

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)



◾ do not chew tablet (for cool mint tablets only)



◾ 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)

◾ do not use if individual blister unit is open or torn.

◾ do not use if printed foil under bottle cap is open or torn



◾ store at 20 0-25 0​C (68 0​-77 0​F)

◾ avoid excessive heat or humidity



◾ this product is sodium and sugar free

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Ranitidine 150 mg





Inactive Ingredients (INACTIVE INGREDIENTS)

For 150 mg:croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,talcum, titanium dioxide



For 150 mg cool mint:acacia, croscarmellose sodium, FD&C Blue No. 1,magnesium stearate, menthol, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, talcum,

titanium dioxide

Questions Or Comments? (Questions or comments?)

•Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM EST.

This product is not manufactured or distributed by Boehringer Ingelheim ® consumer health care products, distributor of Zantac 150mg and 150mg Cool Mint

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

ask a health professional before use.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

◾ 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.

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

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.

Read the Directions and Warnings Before Use. (Read the directions and warnings before use.)

Keep the carton. It contains important information including tips for managing heartburn.

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 andfried foods, chocolate, caffeine, alcohol, even some fruits and vegetables.



•Eat slowly and do not eat big 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


Advanced Ingredient Data


Raw Label Data

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