Label: MAXIMUM STRENGTH HEARTBURN RELIEF- ranitidine hydrochloride tablet
- NDC Code(s): 33992-0620-1
- Packager: GREENBRIER INTERNATIONAL, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each tablet)
Ranitidine 150 mgClose
(as ranitidine hydrochloride USP, 168 mg)
- relieves heartburn associated with acid indigestion and sour stomach
- prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages
Allergy alert: Do not use if you are allergic to ranitidine or any 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 you have
- frequent chest pain
- frequent wheeing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- had heartburn over 3 months. This may be a sign of a more serious condition.
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- heartburn with lightheadedness, sweating, or dizziness
Stop use and ask a 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 (1-800-222-1222) right away.
- 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)
- children under 12 years: ask a doctor
- adults and children 12 years and over:
- Other information
- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
- store at 20º-25ºC (68º-77ºF)
- avoid excessive heat or humidity
- this product is sodium and sugar free
- see end flap for expiration date and lot number
- Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hyrpomellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxideClose
- Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-FridayClose
- Principal display panel
COMPARE TO ACTIVE INGREDIENT OF MAXIMUM STRENGTH ZANTAC 150®*
• Ranitidine 150 mg - Acid Reducer
Relieves and prevents heartburn due to acid indigestion
DOES NOT CONTAIN GLUTEN
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Zantac 150®.
Product of India
Distributed by: Greenbrier International, Inc.
Chesapeake, VA 23320 USA
TAMPER EVIDENT: DO NOT USE IF CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN
- INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH HEARTBURN RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0620 Route of Administration ORAL DEA Schedule 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK Score no score Shape OVAL Size 12mm Flavor Imprint Code 9R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-0620-1 1 in 1 CARTON 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200536 06/15/2013 Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)