Ranitidine 75: Package Insert and Label Information

RANITIDINE 75- ranitidine hydrochloride tablet
The Kroger Co.

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Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 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

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 Breat Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

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)
  • children under 12 years: ask a doctor

Other information

  • this product is sodium and sugar free
  • Blister: do not use if individual blister unit is open or torn
    Bottle: do not use if printed foil under bottle cap is open or torn
  • avoid excessive heat or humidity
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Question Section

Questions? call 1-888-375-3784

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information .

Package Label Principal Display Panel

Ranitidine Tablets USP, 75 mg — container label

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Ranitidine Tablets USP, 75 mg — Container carton label

Ranitidine Tablets USP, 75 mg — Container carton label

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(click image for full-size original)
RANITIDINE 75
ranitidine tablets usp, 75mg tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-131(NDC:55111-131)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ranitidine hydrochloride (ranitidine) ranitidine 75 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
magnesium stearate
cellulose, microcrystalline
Polyethylene Glycol, Unspecified
Ferrosoferric Oxide
titanium dioxide
Product Characteristics
Color PINK Score no score
Shape ROUND Size 7mm
Flavor Imprint Code P75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-131-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-131-30)
2 NDC:30142-131-60 1 BOTTLE in 1 CARTON contains a BOTTLE
2 60 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-131-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075294 03/31/2011
Labeler — The Kroger Co. (006999528)

Revised: 12/2019 The Kroger Co.

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