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heartburn prevention

HEB Heartburn Prevention Drug Facts

Approved
Approval ID

f7156440-f2d8-4292-a436-388622ff3965

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

H E B

DUNS: 007924756

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cimetidine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59640-022
Application NumberANDA075285
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cimetidine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (9)

CIMETIDINEActive
Quantity: 200 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/26/2025

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)

![022-1j-heartburn-prevention.jpg](/dailymed/image.cfm?name=022-1j-heartburn- prevention.jpg&id=895060)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/19/2022

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/19/2022

Active ingredient (in each tablet)

Cimetidine 200 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/19/2022

Purpose

Acid reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 5/19/2022

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).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/19/2022

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 

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 11/14/2022

Other information

store at 20°-25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/19/2022

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/14/2022

Questions or comments?

1-800-719-9260

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