Regular StrengthRanitidine Tablets USP, 75 mg Drug Facts

Acid Reducer by

Drug Labeling and Warnings

Acid Reducer by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Strides Pharma Science Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACID REDUCER - ranitidine hydrochloride tablet, film coated 
Strides Pharma Inc

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Regular Strength
Ranitidine Tablets USP, 75 mg

Drug Facts

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
•   kidney disease

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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

• TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
• store at 20° - 25° C (68° - 77° F)
• avoid excessive heat or humidity
• this product is sugar free

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide

Questions?

Call 1-877-244-9825

Tips for managing heartburn

• Do not lie flat or bend over soon after eating
• Do not eat late at night, or just before bedtime
• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
• Eat slowly and do not eat big meals
• If you are overweight, lose weight
• If you smoke, quit smoking
• Raise the head of your bed
• Wear loose fitting clothing around your stomach

Do not discard this carton. It contains important consumer information.

Manufactured by:

Strides Pharma Science Ltd.

Puducherry - 605 014, India.

PON/DRUGS/16 13 4193

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 04/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ranitidine Tablets, USP 75 mg

NDC  59556-945-04

30's count - Container Label

Ranitidine Tablets, USP 75 mg

NDC  59556-945-04

30's count - Carton Label

Ranitidine Tablets, USP 75 mg

NDC  59556-945-01

10's count – Blister Foil

Ranitidine Tablets, USP 75 mg

NDC  59556-945-01

10's count – Blister Carton Label

Ranitidine Tablets, USP 75 mg

NDC  59556-945-08

1000's count - Container Label

ACID REDUCER 
ranitidine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-945
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	75 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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	OR;606
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-945-04	1 in 1 CARTON	12/31/2020	10/27/2022
1		30 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	ANDA201745	12/31/2020	10/27/2022

Labeler - Strides Pharma Inc (078868278)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Pharma Science Limited		871402375	ANALYSIS(59556-945) , MANUFACTURE(59556-945) , PACK(59556-945)

Revised: 10/2022

Document Id: 534b48c0-1967-4bfa-b5e6-e3afd0aefce4

34390-5

Set id: a33bd585-e218-4ff0-9d8d-7c2fe858ddf2

Version: 4

Effective Time: 20221027