DailyMed - RANITIDINE tablet

NDC Code(s): 55111-131-04, 55111-131-14, 55111-131-30, 55111-131-37, view more
55111-131-45, 55111-131-60, 55111-131-79, 55111-131-80, 55111-131-81, 55111-131-90
Packager: Dr. Reddy's Laboratories Limited

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 23, 2025

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Active ingredient (in each tablet)
Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 mg)

Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 mg)
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Purpose
Acid reducer

Acid reducer
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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 ...
- 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
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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 ...
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 (1-800-222-1222).

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

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
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QUESTIONS
Questions? call 1-888-375-3784 - Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Questions? call 1-888-375-3784

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.
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PRINCIPAL DISPLAY PANEL
Ranitidine Tablets USP, 75 mg - container label

Ranitidine Tablets USP, 75 mg - container label

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PRINCIPAL DISPLAY PANEL
Ranitidine Tablets USP, 75 mg - Container CartonLabel

Ranitidine Tablets USP, 75 mg - Container CartonLabel

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INGREDIENTS AND APPEARANCE

Product Information

RANITIDINE ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-131
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ranitidine hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7)	ranitidine	75 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
ferrosoferric oxide (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	P75
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-131-30	1 in 1 CARTON	03/01/2000
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:55111-131-60	1 in 1 CARTON	03/01/2000
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:55111-131-80	1 in 1 CARTON	03/01/2000
3		80 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:55111-131-90	1 in 1 CARTON	03/01/2000
4		90 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:55111-131-04	1 in 1 CARTON	03/01/2000
5		120 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:55111-131-37	1 in 1 CARTON	03/01/2000
6		160 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:55111-131-79	1 in 1 CARTON	03/01/2000
7		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC:55111-131-14	2 in 1 CARTON	03/01/2000
8		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC:55111-131-81	3 in 1 CARTON	03/01/2000
9		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC:55111-131-45	1 in 1 CARTON	03/01/2000
10		45 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075294	03/01/2000

Labeler - Dr. Reddy's Laboratories Limited (650562841)

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Published Date (What is this?)	Version	Files
May 29, 2025	11 (current)	download
Nov 14, 2019	10	download
Jun 15, 2018	9	download
Jul 22, 2013	6	download
Oct 19, 2011	3	download

	RxCUI	RxNorm NAME	RxTTY
1	312773	ranitidine 75 MG Oral Tablet	SCD
2	312773	ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral Tablet	SY

Label: RANITIDINE tablet

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	55111-131-04
2	55111-131-14
3	55111-131-30
4	55111-131-37
5	55111-131-45
6	55111-131-60
7	55111-131-79
8	55111-131-80
9	55111-131-81
10	55111-131-90

Label: RANITIDINE tablet

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

RANITIDINE tablet

Number of versions: 5

RANITIDINE tablet

RANITIDINE tablet

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RANITIDINE tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.