RANITIDINE 150 COOL MINT- ranitidine hydrochloride tablets 150mg tablet, coated

Ranitidine 150 by

Drug Labeling and Warnings

Ranitidine 150 by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Ranitidine 150mg (as ranitidine hydrochloride, USP 168mg)

Purpose

 Acid reducer

Uses

• 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

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 you have

• frequent chest pain
• frequent wheezing, 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.
• 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

Stop use and ask a doctor if

• your heartburn continues or worsens
• you need to take this product for more than 14 days

If pregnant or breast-feeding,

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 (1-800-222-1222) right away.

Directions

adults and children 12 years of age 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

Other information

• do not use if the individual blister unit is open or torn
• store at 20ºC to 25ºC (68ºF to 77ºF)
• avoid excessive heat or humidity
• protect from light
  

Inactive ingredients

carnauba wax, colloidal silicon dioxide, cool vanilla mint flavor, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide

Questions or comments?

1-888-952-0050 Monday through Friday 9AM-5PM EST

Principal Display Panel

Ranitidine 150mg Cool Mint

INGREDIENTS AND APPEARANCE

RANITIDINE 150  COOL MINT
ranitidine hydrochloride tablets 150mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-389
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-389-29	1 in 1 CARTON	01/05/2010
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69168-389-02	150 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078192	01/05/2010

Labeler - Allegiant Health (079501930)