DailyMed - RANITIDINE tablet, coated

NDC Code(s): 55111-404-02, 55111-404-17, 55111-404-24, 55111-404-32, view more
55111-404-34, 55111-404-36, 55111-404-38, 55111-404-40, 55111-404-50, 55111-404-55, 55111-404-61, 55111-404-62, 55111-404-65, 55111-404-90
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 150 mg (as ranitidine hydrochloride USP, 168 mg)

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)
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Purpose
Acid reducer

Acid reducer
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Use(s)
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 stools.These ...
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 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)
- children under 12 years: ask a doctor
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Other information
do not use if printed foil under bottle cap is open or torn - store at 20°-25°C (68°-77°F) avoid excessive heat or humidity - protect from light - this product is sodium and sugar free
- do not use if printed foil under bottle cap is open or torn
- store at 20°-25°C (68°-77°F)
- avoid excessive heat or humidity
- protect from light
- this product is sodium and sugar free
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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?
Call 1-888-375-3784 - Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

Call 1-888-375-3784

Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

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SPL UNCLASSIFIED SECTION
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 ...
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, and even some fruits and vegetables.
- Eat slowly and do not eat beig 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.
Revised: 03/20
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PACKAGE LABEL PRINCIPAL DISPLAY PANEL
Container Label: Dr.Reddy's - NDC 55111-404-34 - Maximum Strength - Ranitidine - Tablets USP,150 mg - ACID REDUCER - PREVENTS & RELIEVES - HEARTBURN associated with acid indigestion - and sour ...

Container Label:

Dr.Reddy's
NDC 55111-404-34

Maximum Strength
Ranitidine
Tablets USP,150 mg
ACID REDUCER

PREVENTS & RELIEVES
HEARTBURN associated with acid indigestion
and sour stomach

24 Tablets(24 doses)

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PRINCIPAL DISPLAY PANEL
Container Carton Label: Dr.Reddy's - NDC 55111-404-34 - Compare to the active - ingredient in Zantact 150® Tablets* Maximum Strength - Ranitidine - Tablets USP,150 mg - ACID REDUCER - PREVENTS ...

Container Carton Label:

Dr.Reddy's
NDC 55111-404-34

Compare to the active
ingredient in Zantact 150® Tablets*

Maximum Strength
Ranitidine
Tablets USP,150 mg
ACID REDUCER

PREVENTS & RELIEVES
heartburn associated with acid indigestion
and sour stomach

24 Tablets(24 doses)

Close
PRINCIPAL DISPLAY PANEL
Blister Carton Label: Dr.Reddy's - NDC 55111-404-24 - Maximum Strength - Ranitidine - Tablets USP,150 mg - ACID REDUCER - PREVENTS & RELIEVES - HEARTBURN associated with acid indigestion - and sour ...

Blister Carton Label:

Dr.Reddy's
NDC 55111-404-24

Maximum Strength
Ranitidine
Tablets USP,150 mg
ACID REDUCER

PREVENTS & RELIEVES
HEARTBURN associated with acid indigestion
and sour stomach

24 Tablets(24 doses)

Close

INGREDIENTS AND APPEARANCE

Product Information

RANITIDINE ranitidine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-404
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ranitidine Hydrochloride (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	150 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	R150
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-404-34	1 in 1 CARTON	12/02/2009
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:55111-404-32	1 in 1 CARTON	12/02/2009
2		32 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:55111-404-36	1 in 1 CARTON	12/02/2009
3		36 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:55111-404-50	1 in 1 CARTON	12/02/2009
4		50 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:55111-404-61	1 in 1 CARTON	12/02/2009
5		65 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:55111-404-55	2 in 1 CARTON	01/05/2010
6		65 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:55111-404-62	1 in 1 CARTON	12/02/2009
7		95 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:55111-404-90	2 in 1 CARTON	12/02/2009
8		95 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:55111-404-02	1 in 1 CARTON	12/02/2009
9		200 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC:55111-404-65	1 in 1 CARTON	12/02/2009
10		220 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC:55111-404-17	1 in 1 CARTON	12/02/2009
11		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
12	NDC:55111-404-24	3 in 1 CARTON	12/02/2009
12		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
13	NDC:55111-404-38	4 in 1 CARTON	12/02/2009
13		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
14	NDC:55111-404-40	1 in 1 BOTTLE	12/02/2009
14		40 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	ANDA078192	12/02/2009

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

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Published Date (What is this?)	Version	Files
Jun 2, 2025	12 (current)	download
Apr 22, 2020	11	download
Aug 1, 2019	10	download
Sep 14, 2018	9	download
Jul 19, 2018	8	download
Sep 11, 2015	6	download
Oct 19, 2011	3	download

	RxCUI	RxNorm NAME	RxTTY
1	198191	ranitidine 150 MG Oral Tablet	SCD
2	198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY

Label: RANITIDINE tablet, coated

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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 doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	55111-404-02
2	55111-404-17
3	55111-404-24
4	55111-404-32
5	55111-404-34
6	55111-404-36
7	55111-404-38
8	55111-404-40
9	55111-404-50
10	55111-404-55
11	55111-404-61
12	55111-404-62
13	55111-404-65
14	55111-404-90

Label: RANITIDINE tablet, coated

View Package Photos

VIEW MORE

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 doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

RANITIDINE tablet, coated

Number of versions: 7

RANITIDINE tablet, coated

RANITIDINE tablet, coated

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RANITIDINE tablet, coated

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