RxNorm Names
Review RxNorm Normal Forms
PEPTO-BISMOL
(bismuth subsalicylate)
tablet, chewable
[Lil' Drug Store Products, Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=dd2f2205-34d1-4960-bf37-bb8d534cd0e1| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
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
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
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 exceed 8 doses (16 tablets) in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other information
- each tablet contains: calcium 140 mg
- sodium less than 1 mg
- salicylate 102 mg
- very low sodium
- sugar free
- avoid excessive heat (over 104°F or 40°C)
Inactive ingredients
calcium carbonate, flavor, magnesium stearate, mannitol, povidone, red 27 aluminum lake, saccharin sodium, talc
| PEPTO-BISMOL
bismuth subsalicylate tablet, chewable |
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| Labeler - Lil' Drug Store Products, Inc. (093103646) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| CCB Packaging Inc. | 362374464 | REPACK(66715-9723), RELABEL(66715-9723) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| The Proctor & Gamble Manufacturing Company | 007130032 | MANUFACTURE(66715-9723) | |
Revised: 01/2013
Document Id: 045455cf-fd71-409a-be8b-60b2796f057c
Set id: dd2f2205-34d1-4960-bf37-bb8d534cd0e1
Version: 3
Effective Time: 20130110
Lil' Drug Store Products, Inc.
