NDC | 0363-0852-01, 0363-0852-09, 0363-0852-51, 0363-0852-62, 0363-0852-82 |
Set ID | 7770ba0d-ff68-4b06-997b-93f5034382e1 |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreen Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA091429 |
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers
Do not use
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- 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
- •
- if you have kidney disease, except under the advice and supervision of a doctor
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
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- nausea or vomiting
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- stomach pain
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Directions
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- adults and children 12 years and over:
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- to relieve symptoms, swallow 1 tablet with a glass of water
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- to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
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- 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
- Inactive ingredients
- Questions or comments?
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Consumer Information
What you should know about MAXIMUM STRENGTH
Ranitidine Tablets, 150 mg
Acid Reducer
(Please read all of this information before taking MAXIMUM STRENGTH Ranitidine Tablets, 150 mg. Save this leaflet for future reference.)
What are MAXIMUM STRENGTH Ranitidine Tablets, 150 mg?
• MAXIMUM STRENGTH Ranitidine Tablets, 150 mg contain 150 mg of ranitidine (as ranitidine hydrochloride, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide.
Excellent Safety Record
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- The ingredient in MAXIMUM STRENGTH Ranitidine Tablets, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets, 150 mg has been taken safely with many frequently prescribed medications.
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- MAXIMUM STRENGTH Ranitidine Tablets, 150 mg are sodium and sugar free.
What symptoms do MAXIMUM STRENGTH Ranitidine Tablets, 150 mg relieve and prevent?
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- MAXIMUM STRENGTH Ranitidine Tablets, 150 mg relieve and prevent heartburn associated with acid indigestion and sour stomach.
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- Certain foods or beverages, and even lying down to sleep can cause heartburn associated with acid indigestion and sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.
How should I take MAXIMUM STRENGTH Ranitidine Tablets, 150 mg?
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- To relieve symptoms, swallow 1 tablet with a glass of water.
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- To prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn.
- •
- This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours).
- •
- MAXIMUM STRENGTH Ranitidine Tablets, 150 mg should not be given to children under 12 years old unless directed by a doctor.
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- Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers
How do MAXIMUM STRENGTH Ranitidine Tablets, 150 mg work?
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- MAXIMUM STRENGTH Ranitidine Tablets, 150 mg reduce the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets, 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.
Tips for managing heartburn
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- Do not lie flat or bend over soon after eating
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- Do not eat late at night, or just before bedtime
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- Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables.
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- Eat slowly and do not eat big meals
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- If you are overweight, lose weight
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- If you smoke, quit smoking
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- Raise the head of your bed
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- Wear loose fitting clothing around your stomach
When should I see 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
- •
- if you have kidney disease, except under the advice and supervision of a doctor
- •
- 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
- •
- Stop use and ask a doctor if
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- your heartburn continues or worsens
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- you need to take this product for more than 14 days
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- If pregnant or breast-feeding, ask a healthcare professional before use.
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- 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).
Questions or comments? 1-800-719-9260
BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn.
BLISTERS: Do not use if the individual blister unit is open or torn.
Distributed by
Perrigo®
Allegan, MI 49010
: 85251 00 J3
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
WAL ZAN 150
ranitidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0852 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 150 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BROWN (Pinkish) Score no score Shape ROUND Size 10mm Flavor Imprint Code L852 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0852-62 24 in 1 CARTON 01/11/2019 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0363-0852-82 1 in 1 CARTON 01/11/2019 2 200 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0363-0852-09 1 in 1 CARTON 01/31/2019 3 65 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0363-0852-01 1 in 1 CARTON 01/31/2019 4 95 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0363-0852-51 8 in 1 CARTON 03/12/2019 5 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091429 01/11/2019 Labeler - Walgreen Company (008965063)