FDA Label for Goodsense Regular Strength Stomach Relief 122
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGRADIENTS
- PRINCIPAL DISPLAY PANEL
Goodsense Regular Strength Stomach Relief 122 Product Label
The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)
Purpose
Upset stomach reliever and anti-diarrheal
Use(S)
relieves:
• diarrhea• heartburn• indigestion• nausea• upset stomach associated with these symptoms
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
____________________________________________________________________________________________________________
Allergy alert: Contains salicylate. Do not take if you are
• allergic to salicylates (including aspirin)• taking other salicylate products
Do Not Use
if you have
• bloody or black stool• an ulcer• a bleeding problem
Ask A Doctor Before Use If You Have
• fever• mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are
taking any drug for
• anticoagulation (thinning of the blood)• diabetes• gout• arthritis
When Using This Product
a temporary, but harmless darkening of the stool and/or tongue may occur.
Stop Use And Ask Doctor If
• symptoms get worse• ringing in the ears or loss of hearing occurs• diarrhea lasts more than 2 days
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 immediately.
Directions
• chew or dissolve in mouth• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed• do not take more than 8 doses (16 tablets) in 24 hours• children under 12 years: ask a doctor• drink plenty of clear fluids to help prevent dehydration caused by diarrhea• use until diarrhea stops but not more than 2 days
Other Information
• each tablet contains:• sodium less than 1 mg• salicylate 102 mg• very low sodium• avoid excessive heat (over 104oF or 40oC).• TAMPER EVIDENT: Do not use if individual compartments are torn or open.
Inactive Ingradients
calcium carbonate, D&C red 27 aluminum lake, flavor, Magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.
Principal Display Panel
OODSENSE ®
Regular Strength
NDC 50804-152-49
Stomach Relief Tablets
Bismuth Subsalicylate 262 mg
Antidiarrheal/Upset Stomach Reliever
Soothing Relief For
5 Symptoms
• Upset Stomach• Indigestion• Heartburn• Nausea• Diarrhea
Actual Size
* Compare to active ingredient of Pepto-Bismol® Chewable Tablets
30 Chewable Tablets
NDC 68788-4002-3
Relabeled By: Preferred Pharmaceuticals Inc.
* Please review the disclaimer below.
