FDA Label for Pep Tum
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- REYE’S SYNDROME
- ALLERGY ALERT
- DO NOT USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU
- STOP USE AND ASK A DOCTOR IF
- WHEN USING THIS PRODUCT
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- INACTIVE INGREDIENTS
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Pep Tum Product Label
The following document was submitted to the FDA by the labeler of this product First Aid Direct. 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 (In Each Tablet)
Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)
Purpose
Antidiarrheal/Antacid
Uses
- controls diarrhea
- relieves heartburn, indigestion, nausea and upset stomach without constipating
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 Or Pharmacist Before Use If You
- are taking any drug for anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
Stop Use And Ask A Doctor If
- symptoms get worse
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
When Using This Product
a temporary, but harmless, darkening of the stool and/or tongue may occur.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, contact a doctor or Poison Control Center immediately.
Directions
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Adults and Children 12 years and over: 525 mg (2 tablets) every ½ to 1 hour or 1050 mg (4 tablets) every hour as needed
- do not exceed 4200 mg ( 16 tablets) in 24 hours
- use until diarrhea stops but not more than 2 days
- Children under 12 years: ask a doctor
Inactive Ingredients
aspartame, calcium carbonate, , D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide
Package/Label Principal Display Panel
Pep Tum
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