SunMark heartburn relief

Manufacturer
Strategic Sourcing Services LLC
Effective date
2019-11-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:57:28

Label at a glance#

ProductSunMark heartburn relief acid reducer
Active ingredientCIMETIDINE
Label structure10 sections

Indications and 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

Dosage and administration

• 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

• store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cimetidine 200 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

  1. relieves heartburn associated with acid indigestion and sour stomach
  2. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to cimetidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

  1. 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.
  2. with other acid reducers

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  1. frequent chest pain
  2. frequent wheezing, particularly with heartburn
  3. unexplained weight loss
  4. nausea or vomiting
  5. stomach pain
  6. had heartburn over 3 months. This may be a sign of a more serious condition.
  7. heartburn with lightheadedness, sweating or dizziness
  8. chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  9. kidney disease
  10. liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking
  • a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  1. adults and children 12 years and over:
  2. to relieve symptoms, swallow 1 tablet with a glass of water
  3. 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
  4. do not take more than 2 tablets in 24 hours
  5. children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  1. store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Consumer Information

SPL UNCLASSIFIED SECTION

Cimetidine Tablets, 200 mg

Acid Reducer

For Heartburn

In clinical studies, Cimetidine Tablets, 200 mg was significantly better than placebo tablets in relieving and preventing heartburn symptoms.

Percent of Heartburn Episodes Relieved

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Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken 30 Minutes Before a Meal

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Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken at Time of Meal

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Drug Interaction Warnings:

Cimetidine Tablets, 200 mg affects some prescription medicines causing slightly higher levels of those medicines in the blood. Higher blood levels could lead to side effects in rare situations. If you currently take Theophylline (oral asthma medicine), Warfarin (blood thinning medicine) or Phenytoin (seizure medicine), consult your doctor before taking this product.

Brand names of some medicines which contain one of these ingredients include:

THEOPHYLLINE

THEO-DUR® Theochron® Slo-Bid® Uniphyl® Theo-24®

WARFARIN

Coumadin®

PHENYTOIN

Dilantin®

There may be other medicines that contain one of these ingredients. If in doubt about this or about possible effects of Cimetidine Tablets, 200 mg on any other medicines you are taking, talk to your doctor or pharmacist.

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, even some fruits and vegetables
  • Eat slowly and do not eat big 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

Read the directions and warnings before taking this medication.

Questions or Comments?

1-800-719-9260

Distributed By

Perrigo®

Allegan, MI 49010

Rev 08/19

02200 00 J5

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO TAGAMET® HB 200 ACTIVE INGREDIENT

heartburn relief cimetidine tablets USP, 200 mg

Acid Reducer

Just one tablet relieves and prevents heartburn and acid indigestion

TAKE ANY TIME YOU NEED IT:

Before Meal

During Meal

After Meal

Actual Size

ONE TABLET DOSE

Read and retain the important information and drug interaction warnings printed on the product information sheet

30 TABLETS (30 DOSES)

022-s1-heartburn-relief.jpg
022-s1-heartburn-relief.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-246-44EA - Each49348-246fa0810c8-81a4-4e22-ae9e-72f286ee0b7612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGD1
CIMETIDINEACTIVE MOIETY80061L1WGD1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-24649348-246-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075285-001CIMETIDINECIMETIDINE200MGTABLET / ORAL1998-10-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2984e616aacf4f…
2026-08-18 06:07:402026-07A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-293f01610625f2…
2019-09-15 20:21 UTC2019-09A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075285-001CIMETIDINE200MGTABLET / ORAL1998-10-29f41ea6bd6efb…

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OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
869054ff-c590-44c0-b501-4461959cdc61af3fb1fb-9871-46d7-b8ff-ab6fcb8042832024-12-23WarningsExact identifier
spl set id: af3fb1fb-9871-46d7-b8ff-ab6fcb804283

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.