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NDC 59640-0022-72 heartburn prevention 200 mg/1 Details

heartburn prevention 200 mg/1

heartburn prevention is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by H E B. The primary component is CIMETIDINE.

Product Information

NDC	59640-0022
Product ID	59640-022_f3a83cc0-2388-49a7-ae02-d0894e20cacc
Associated GPIs
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	heartburn prevention
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	H E B
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 59640-0022-72 (59640002272)

Pricing Information	N/A
NDC Package Code	59640-022-72
Billing NDC	59640002272
Package	1 BOTTLE in 1 CARTON (59640-022-72) / 60 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2022-11-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f7156440-f2d8-4292-a436-388622ff3965 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 foods 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 30 minutes 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?

1-800-719-9260

Principal Display Panel

Compare to Tagamet® HB 200 active ingredient

H-E-B®

Heartburn Prevention

Cimetidine Tablets, 200 mg

Acid Reducer

Just One Tablet Relieves and Prevents Heartburn and Acid Indigestion

Take Anytime You Need It:

• Before Meal

• During Meal

• After Meal

actual size

60 TABLETS (60 DOSES)

INGREDIENTS AND APPEARANCE

HEARTBURN PREVENTION

cimetidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59640-022
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:59640-022-72	1 in 1 CARTON	11/04/2022
1		60 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	11/04/2022

Labeler - H E B (007924756)

Revised: 11/2022

Document Id: f3a83cc0-2388-49a7-ae02-d0894e20cacc

Set id: f7156440-f2d8-4292-a436-388622ff3965

Version: 2

Effective Time: 20221114