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  5. Label Information: Ranitidine Cool Mint

FDA Label for Ranitidine Cool Mint

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. STOP USE AND ASK DOCTOR IF
    8. PREGNANCY/BREASTFEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. CONSUMER INFORMATION
    15. PRINCIPAL DISPLAY PANEL

Ranitidine Cool Mint Product Label

The following document was submitted to the FDA by the labeler of this product Granules India Ltd. 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



◾ do not use if printed foil under bottle cap is open or torn
◾ avoid excessive heat or humidity
◾ store at 20 0-25 0​C (68 0​-77 0​F)
◾ 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




Principal Display Panel



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62207-774-32.jpg - 62207 774 32


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