STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid 
Care One (American Sales Company)

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Drug Facts

Active ingredient (in each 30 mL)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

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

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

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)

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 or last more than 2 days
  • 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 childen.

In case of overdose, get medical help or contact a Posion Control Center right away. (1-800-222-1222)

Directions

Other information

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol®*

REGULAR STRENGTH

STOMACH RELIEF

Bismuth Subsalicylate 525mg

Upset Stomach Reliever/Antidiarrheal

Original Flavor

5SYMPTOM DIGESTIVE RELIEF:

NAUSEA, HERTBURN, INDIGESTION, UPSET STOMACH, DIARRHEA

ALCOHOL FREE

SUGAR FREE

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company, Pepto-Bismol® is a registered trademark of The Protecter & Gamble Company.

TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: FOODHOLD U.S.A., LLC, LANDOVER, MD 20785

For product questions or concerns, contact us at 1-877-846-9949

Package Label

Bismuth Subsalicylate 525 mg

CAREONE Regular Strength Stomach Relief

STOMACH RELIEF  REGULAR STRENGTH
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-372
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 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)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-372-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2018
2NDC:41520-372-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2018
3NDC:41520-372-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00809/30/2018
Labeler - Care One (American Sales Company) (809183973)

Revised: 10/2023
Document Id: 6b8507fa-302f-440b-b66a-b46aa17e04b7
Set id: 062011d2-1e1e-4b0e-8433-b035f3d0c35e
Version: 4
Effective Time: 20231005
 
Care One (American Sales Company)