Active Ingredient(S)
Ranitidine 150 mg
Ranitidine Tablet
FDA Label NDC 62207-774
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Granules India Ltd for the product Ranitidine (NDC 62207-774). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, stop use and ask doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
◾ do not use if printed foil under bottle cap is open or torn
◾ avoid excessive heat or humidity
◾ store at 20
0-25
0C (68
0-77
0F)
◾ this product is sodium and sugar free
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 PST
Consumer Information
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