FAMILY CARE STOMACH RELIEF- bismuth subsalicylate liquid

Family Care Stomach Relief by

Drug Labeling and Warnings

Family Care Stomach Relief by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 30 mL dose cup)                                                       Purpose

Bismuth subsalicylate 525 mg..........................Upset stomach reliever and antidiarrheal

PURPOSE

Uses

relieves

• diarrhea
• heartburn
• indigestion
• nausea
• gas
• belching
• fullness

WARNINGS

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 salicytate products

DO NOT USE

Do not use if you have

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

ASK DOCTOR

Ask a doctor before use if you have

• fever
• mucus in the stool

Ask a doctor before use if you are taking any drug for

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

WHEN USING

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

• diarrhea lasts more than 2 days
• symptoms get worse
• ringing in the ears or loss of hearing occurs

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• shake well before use
• for accurate dosing, use dose cup
• adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed
• do not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours
• use until diarrhea stops but not more than 2 days
• children under 12 years: ask a doctor
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea

STORAGE AND HANDLING

Other information

• each 30 mL dose cup contains: sodium 10 mg
• salicylate 202 mg
• magnesium 25 mg
• protect from freezing
• avoid excessive heat (over 104° or 40°C)
• low sodium

INACTIVE INGREDIENT

Inactive ingredients

FD&C Red No. 3, FD&C Red No. 40, hypromelloses, L-menthol, magnesium aluminum silicate, mint essence, polysorbate 80, propylene glycol, propylparaben, purified water, salicylic acid, sodium saccharin, sodium salicylate, sorbic acid, sucrose, xanthan gum

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

Cerritos, CA 90703 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE STOMACH RELIEF 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-626
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	1050 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MENTHOL (UNII: L7T10EIP3A)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-626-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	07/31/2015

Labeler - United Exchange Corp. (840130579)