Assured 44-319-Delisted
Drug Labeling and Warnings
Drug Details [pdf]
STOMACH RELIEF MULTI-SYMPTOM- bismuth subsalicylate tablet, chewable
GREENBRIER INTERNATIONAL, INC.
Disclaimer: 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.
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Assured 44-319-Delisted
Uses
relieves:
- diarrhea
- traveler's diarrhea
- upset stomach due to overindulgence in food and drink, including:
- indigestion
- nausea
- heartburn
- belching
- fullness
- gas
Warnings
Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use his 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 others 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
- drink of plenty of clear fluids to help prevent dehydration caused by diarrhea
- 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
Other information
- each tablet contains: calcium 40 mg, salicylate 102 mg
- TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- see end flap for expiration date and lot number
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid excessive heat
- store in a dry place
Inactive ingredients
calcium carbonate, cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, mannitol, povidone, saccharin sodium, stearic acid, talc
Principal display panel
Assured ™
COMPARE TO ACTIVE INGREDIENT OF PEPTO-BISMOL®*
MULTI-SYMPTOM
Stomach Relief
Bismuth subsalicylate 262 mg
Upset Stomach Reliever
Anti-diarrheal
Cherry
Multi-Symptom Relief of
Nausea, Upset Stomach,
Heartburn, Diarrhea,
Indigestion
30 chewable tablets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 ORG021531901
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®.
Item # 229932
DISTRIBUTED BY: GREENBRIER INTERNATIONAL INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
ASSURED 44-319
| STOMACH RELIEF
MULTI-SYMPTOM
bismuth subsalicylate tablet, chewable |
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| Labeler - GREENBRIER INTERNATIONAL, INC. (610322518) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(33992-0319) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(33992-0319) | |