RANITIDINE- ranitidine hydrochloride tablet, film coated

Ranitidine by

Drug Labeling and Warnings

Ranitidine by is a Otc medication manufactured, distributed, or labeled by H-E-B, Apotex Inc., Apotex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

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

                                 

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 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 you have

• 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 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 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
• children under 12 years: ask a doctor

Other information

• do not use if seal under bottle cap is broken or missing (bottles)
• do not use if individual blister unit is open or torn (blisters)
• store at 20°C to 25°C (68°F to 77°F)
• avoid excessive heat or humidity
• this product is sodium and sugar free

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?

Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time) 

PRINCIPAL DISPLAY PANEL

Cool Mint Tablets

Maximum Strength

Acid Reducer

Ranitidine Tablets USP, 150 mg - Bottle Label - 24 Tablets

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Releases a Cooling Sensation in Mouth & Throat

Sugar Free

Distributed by: HEB

PRINCIPAL DISPLAY PANEL

Cool Mint Tablets

Maximum Strength

Acid Reducer

Ranitidine Tablets USP, 150 mg - Carton Label - 24 Tablets

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Releases a Cooling Sensation in Mouth & Throat

Sugar Free

Distributed by: HEB

INGREDIENTS AND APPEARANCE

RANITIDINE 
ranitidine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-303
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)
Hypromelloses (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Polydextrose (UNII: VH2XOU12IE)
Titanium Dioxide (UNII: 15FIX9V2JP)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-303-02	1 in 1 CARTON	01/25/2018
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200172	01/25/2018

Labeler - H-E-B (007924756)

Registrant - Apotex Inc. (209429182)

Establishment
Name	Address	ID/FEI	Business Operations
Apotex Inc		209429182	analysis(37808-303) , manufacture(37808-303)