FDA Label for Ranitidine
View Indications, Usage & Precautions
Ranitidine Product Label
The following document was submitted to the FDA by the labeler of this product Avpak. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Ranitidine 150 mg
Purpose
Acid reducer
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
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
◾ 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 Doctor If
◾ your heartburn continues or worsens
◾ you need to take this product for more than 14 days
Pregnancy/Breastfeeding
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.
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
Other Information
· safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
· store between 20°and 25°C (68°and 77°F)
· protect from excessive moisture and light
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 1-855-361-3993
Consumer Information
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