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NDC 49348-0246-44 SunMark heartburn relief 200 mg/1 Details
SunMark heartburn relief 200 mg/1
SunMark heartburn relief is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 49348-0246-44Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cimetidine
Product Information
| NDC | 49348-0246 |
|---|---|
| Product ID | 49348-246_9365412b-ed13-4ed9-8252-f5c2f0e61049 |
| Associated GPIs | 49200010000305 |
| GCN Sequence Number | 011665 |
| GCN Sequence Number Description | cimetidine TABLET 200 MG ORAL |
| HIC3 | Z2D |
| HIC3 Description | HISTAMINE H2-RECEPTOR INHIBITORS |
| GCN | 46750 |
| HICL Sequence Number | 004518 |
| HICL Sequence Number Description | CIMETIDINE |
| Brand/Generic | Generic |
| Proprietary Name | SunMark heartburn relief |
| Proprietary Name Suffix | acid reducer |
| 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 | Strategic Sourcing Services LLC |
| 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 49348-0246-44 (49348024644)
| NDC Package Code | 49348-246-44 |
|---|---|
| Billing NDC | 49348024644 |
| Package | 1 BOTTLE in 1 CARTON (49348-246-44) / 30 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2003-09-19 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.143 |
| Pricing Unit | EA |
| Effective Date | 2021-03-17 |
| NDC Description | SM ACID REDUCER 200 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2022-03-16 |
Standard Product Labeling (SPL)/Prescribing Information SPL af3fb1fb-9871-46d7-b8ff-ab6fcb804283 Details
Uses
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.
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
Inactive ingredients
Consumer Information
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
Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken 30 Minutes Before a Meal
Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken at Time of Meal
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
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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)
INGREDIENTS AND APPEARANCE
| SUNMARK HEARTBURN RELIEF
ACID REDUCER
cimetidine tablet, film coated |
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| Labeler - Strategic Sourcing Services LLC (116956644) |