FAMILY WELLNESS STOMACH RELIEF- bismuth subsalicylate tablet, chewable

Family wellness Stomach Relief by

Drug Labeling and Warnings

Family wellness Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services, Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(in each tablet)

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 behaviour 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
• use until diarrhea stops but not more than 2 days
• children under 12 years: ask a doctor
• drink plenty of 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 INGREDIENTS

adipic acid, calcium carbonate, D&C red 27 aluminum lake, FD&C red # 40 aluminum lake, flavors, magnesium stearate, mannitol, povidone, pregelatinized starch, saccharin sodium

PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT IN PEPTO-BISMOL®*

Family Wellness
Stomach Relief
Bismuth Subsalicylate, 262 mg-Anti-diarrheal
RELIEVES 5 MAJOR SYMPTOMS:

• Heartburn
• Indigestion
• Upset stomach
• Diarrhea
• Nausea

Cherry Flavor
30 CHEWABLE TABLETS
NDC: 55319-122-49

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS STOMACH RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-122
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ADIPIC ACID (UNII: 76A0JE0FKJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POVIDONE (UNII: FZ989GH94E)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-122-49	5 in 1 BOX	02/13/2024
1		6 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	part335	02/13/2024

Labeler - Family Dollar Services, Inc. (024472631)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(55319-122)