PINK BISMUTH- bismuth subsalicylate liquid 
RUGBY LABORATORIES

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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rug bismuth

Active ingredient (in each 15 mL tablespoon=TBSP)

Bismuth subsalicylate 262 mg

Purposes

upset stomach reliever and antidiarrheal

Uses

  • relieves upset stomach due to overindulgence in food and drink
  • controls diarrhea

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

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.

Keep out of reach of children. In case of overdose, get medical help or contact a

Poison Control Center right away.

Directions

  • shake well before using
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • for accurate dosing, use dose cup

adults and children 12 years and over

  • take 2 TBSP every 1/2 hour to 1 hour as needed
  • do not exceed 16 TBSP in 24 hours
  • use until diarrhea stops but not more than 2 days
    children under 12 years:

ask a doctor

Other information

  • each TBSP contains: sodium 6 mg. salicylate 130mg
  • protect from freezing
  • avoid excessive heat (over 104F or 40C)
  • store at room temperature
  •   TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.
  • for health information visit www.info-xtra.com for health information

Inactive ingredients

benzoic acid, D and C red no. 22, D and C red no. 28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicyclic acid, simethicone emulsion, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

Call 1-800-645-2158, 9 am - 5 pm ET, Monday-Friday

package Label

Pink Bismuth label

PINK BISMUTH 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1810
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1810-59237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/201211/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33504/01/201211/01/2019
Labeler - RUGBY LABORATORIES (079246066)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP LABORATORIES965480861manufacture(0536-1810)

Revised: 3/2020
 
RUGBY LABORATORIES