FDA Label for Bismuth Subsalicylate
View Indications, Usage & Precautions
- DRUG FACTS
- OTC - PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Bismuth Subsalicylate Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.
Drug Facts
Active ingredient (in each caplet)
Bismuth subsalicylate 262 mg
Otc - Purpose
Purpose
Upset stomach reliever and anti-diarrheal
Uses
relieves: ■ travelers’ diarrhea ■ diarrhea
■ upset stomach due to overindulgence in food and drink, including: ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness
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.
Otc - Do Not Use
Do not use if you have
- an ulcer
- a bleeding problem
- bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
- fever
- mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
Otc - When Using
When using this product a temporary but harmless darkening of the stool and/or tongue may occur.
Otc - Stop Use
Stop use and ask a doctor if
- symptoms get worse or last more than 2 days
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
- swallow caplets with water, do not chew
- 2 caplets (1 dose) every 1/2 hour or 4 caplets (2 doses) every hour as needed for diarrhea
- 2 caplets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (16 caplets) in 24 hours
- use until diarrhea stops but not more than 2 days
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
adults and children 12 years and over:
children under 12 years: ask a doctor
Other Information
- each caplet contains: salicylate 102 mg
- Store in a dry place at 15° – 30°C (59° – 86°F)
- TAMPER EVIDENT: do not use if printed seal under cap is torn or missing
Inactive Ingredient
croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.
Questions Or Comments?
1-800-200-6313
Other
RETAIN THIS CARTON FOR FULL LABELING INFORMATION
WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
COMPARE TO PEPTO-BISMOL active ingredient*
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979
Product of Mexico
* Please review the disclaimer below.