Search by Drug Name or NDC

NDC 49035-0820-76 Equate Cimetidine 200 mg/1 Details

Equate Cimetidine 200 mg/1

Equate Cimetidine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is CIMETIDINE.

MedlinePlus Drug Summary

Cimetidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (esophagus); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome. Over-the-counter cimetidine is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach. Cimetidine is in a class of medications called H2 blockers. It decreases the amount of acid made in the stomach.

Related Packages: 49035-0820-76
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cimetidine

Product Information

NDC	49035-0820
Product ID	49035-820_4c4930d7-ec4b-45eb-8706-d06523a0d198
Associated GPIs	62100005008520 49200010000305
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Equate Cimetidine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cimetidine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	CIMETIDINE
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075285
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0820-76 (49035082076)

Pricing Information	N/A
NDC Package Code	49035-820-76
Billing NDC	49035082076
Package	1 BOTTLE in 1 CARTON (49035-820-76) / 120 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2021-05-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ad3e8f6a-8e35-42c2-a98c-566a2868e923 Details

Active ingredient (in each tablet)

Cimetidine 200 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 food and beverages

Warnings

Allergy alert: Do not use if you are allergic to cimetidine 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

•: frequent chest pain
•: frequent wheezing, particularly with heartburn
•: unexplained weight loss
•: nausea or vomiting
•: stomach pain
•: 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
•: kidney disease
•: liver 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

•: you need to take this product for more than 14 days
•: stomach pain continues
•: your heartburn continues or worsens

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).

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 right before or any time up to 30minutes before eating food or drinking beverages that cause heartburn
•: do not take more than 2 tablets in 24 hours
•: children under 12 years: ask a doctor

Other information

•: store at 20°-25°C (68°-77°F)

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Questions or comments?

1-888-287-1915

Principal Display Panel

equate™

Compare to Tagamet® HB 200 active ingredient

Cimetidine Tablets, 200 mg

Acid Reducer

Heartburn Prevention

Just one tablet relieves and prevents heartburn and acid indigestion

Take Anytime You Need It:

• Before meal

• During meal

• After meal

Actual Size

200 mg

60 TABLETS (60 DOSES)

INGREDIENTS AND APPEARANCE

EQUATE CIMETIDINE

cimetidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-820
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD)	CIMETIDINE	200 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	L022
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-820-72	1 in 1 CARTON	09/27/2006
1		60 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:49035-820-76	1 in 1 CARTON	05/31/2021
2		120 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	ANDA075285	09/27/2006

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 3/2022

Document Id: 4c4930d7-ec4b-45eb-8706-d06523a0d198

Set id: ad3e8f6a-8e35-42c2-a98c-566a2868e923

Version: 6

Effective Time: 20220310