CAREONE STOMACH RELIEF- bismuth subsalicylate tablet, chewable

Careone Stomach Relief by

Drug Labeling and Warnings

Careone Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves: 

• diarrhea 
• heartburn 
• indigestion 
• nausea
• upset stomach associated with these symptoms 

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

• bloody or black stool
• an ulcer
• a bleeding problem

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 of 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 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 immediately.

DIRECTIONS

• chew or dissolve in mouth 
• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed 
• do not take more than 8 doses (16 tablets) in 24 hours
• children under 12 years: ask a doctor 
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea 

OTHER INFORMATION

• each tablet contains:
• sodium less than 1 mg 
• salicylate 102 mg
• very low sodium 
• avoid excessive heat (over 104oF or 40oC).
• TAMPER EVIDENT: Do not use if individual compartments are torn or open.

INACTIVE INGRADIENTS

calcium carbonate, D&C red 27 aluminum lake, flavor, Magnesium stearate, mannitol, pregelatinized  starch, saccharin sodium.

PRINCIPAL DISPLAY PANEL

C 72476-173-72

CAREoneTM

Compare to active ingredient of Pepto-Bismol® Chewable Tablets*

Stomach Relief Tablets

Bismuth Subsalicylate 262 mg

Upset Stomach/Antidiarrheal

EASY TO CHEW

FOR RELIEF OF:

• UPSET STOMACH 
• INDIGESTION 
• HEARTBURN
• NAUSEA
• DIARRHEA

Actual Size

30 Chewable Tablets

INGREDIENTS AND APPEARANCE

CAREONE STOMACH RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-173
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor	MINT	Imprint Code	G122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-173-72	6 in 1 BOX	11/26/2024
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	11/26/2024

Labeler - Retail Business Services, LLC. (967989935)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(72476-173)