PINK BISMUTH- bismuth subsalicylate liquid 
We Care Distributor 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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We Care Pink Bismuth Drug Facts

Active ingredient (in each 15 mL)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever/antidiarrheal

Uses

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 vomitting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrom, a rare but serious illness.

Allergy alert:Contains salicylates. Do not take if you are

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, a sodium-restricted diet, a magnesium restricted diet

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.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

carboxymethylcellulose sodium, D&C red #3, FD&C red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium salicylate, sorbitol, water

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

Compare to Original Pepto-Bismol® active ingredient

ORIGINAL STRENGTH

Stomach Relief

Upset Stomach Reliever/Antidiarrheal

Bismuth Subsalicylate 262 mg

Protective Coating Action

Soothing Relief for 5 Symptoms:

Heartburn

Indigestion

Upset Stomach

Nausea

Diarrhea

Pink Bismuth

PINK BISMUTH 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-047
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorPINK (viscous) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-047-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33510/25/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
PURINE PHARMA LLC019950491manufacture(70005-047)

Revised: 10/2016
Document Id: 74ba1350-728d-4035-9502-c823df2be69e
Set id: 0d049f14-db3b-4ab7-ba97-6574016a6424
Version: 2
Effective Time: 20161025
 
We Care Distributor Inc.