PINK BISMUTH- bismuth subsalicylate tablet, chewable 
Preferred Pharmaceuticals, 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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Drug label

Active Ingredient

Bismuth subsalicylates 262mg...........Antidiarrheal/Antacid

Uses

•
Controls diarrhea
•
relieves heartburn, indigestion, nasea 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 or 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

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an ulcer
•
a bleeding problem
•
bloody or black stool

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

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anticoagulation (thinning 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 a 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.

Dosage and Administration

Adults and Children 12 years and over: 525mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hours as needed.  Do not exceed 4200mg (16 tablets) in 24 hours.  Use until diarrhea stops but not more than 2 days.  Children under 12 years ask a doctor

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Adults and Children 12 years and over: 525mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hours as needed.  Do not exceed 4200mg (16 tablets) in 24 hours.  Use until diarrhea stops but not more than 2 days.  Children under 12 years ask a doctor

Other information:

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Save carton for full directions and warnings
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Store at controlled room temperature 59°- 86°F (°15 - 30°C)
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Do not use is cellophane unit is torn, cut or open.
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Phenylketonurics: Contains phenylalanine 1.1mg per tablet.
•
Calcium content per tablet, 73mg

aspatame, calcium carbonate, D and C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide

Image for Pink Bismuth Label

Pink Bismuth Tablets
PINK BISMUTH 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0190(NDC:0603-0235)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
DEXTRATES (UNII: G263MI44RU)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorpink (Pink) Scoreno score
ShapeROUNDSize15mm
FlavorImprint Code RH046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-0190-330 in 1 BOX; Type 0: Not a Combination Product12/01/201011/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33512/01/201011/11/2019
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Registrant - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022REPACK(68788-0190)

Revised: 11/2019
Document Id: 80d920c4-0757-439e-b0c2-cbbe81109f77
Set id: c069d188-5a79-4885-835b-afb69eaf8a48
Version: 11
Effective Time: 20191111
 
Preferred Pharmaceuticals, Inc