Pink Bismuth by Preferred Pharmaceuticals, Inc Drug label

Drug Details [pdf]

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

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

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.

Other information:

Save carton for full directions and warnings
Store at controlled room temperature 59°- 86°F (°15 - 30°C)
Do not use is cellophane unit is torn, cut or open.
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
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-0190(NDC: 0603-0235)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM CARBONATE (UNII: H0G9379FGK)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	pink (Pink)	Score	no score
Shape	ROUND	Size	15mm
Flavor		Imprint Code	RH046
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 68788-0190-3	30 in 1 BOX; Type 0: Not a Combination Product	12/01/2010	11/11/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	12/01/2010	11/11/2019

Labeler - Preferred Pharmaceuticals, Inc (791119022)

Registrant - Preferred Pharmaceuticals, Inc (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals, Inc		791119022	REPACK(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