STOMACH RELIEF- bismuth subsalicylate liquid

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 30 mL dose )

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

• diarrhea
• travelers’ diarrhea
• upset stomach due to overindulgence in food and drink, including

o heartburn

o gas

o indigestion

o nausea

o fullness

o belching

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

• 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 (1-800-222-1222) right away.

Directions

• mL = milliliter
• shake well before using
• only use dose ready dosing cup provided. Do not use any other dosing device
• adults and children 12 years and over:

o 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea

o 30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

o do not exceed 8 doses (240 mL ) in 24 hours

o use until diarrhea stop but not more than 2 days

• children under 12 years of age: ask a doctor
• drink plenty of clear fluids to help prevent dehydration cause by diarrhea

Other information

• each 30 mL contains: potassium 8 mg, sodium 9 mg
• each 30 mL contains: salicylate 206 mg
• low sodium
• protect from freezing
• avoid excessive heat (over 104ºF or 40ºC)
• supplied in the following oral dosage forms

NDC: 0121-0910-30: 30 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum

Questions or comments?

Call 1-800-845-8210.

PACKAGED BY:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R11/20

Principal Display Panel

Delivers 30 mL

NDC: 0121-0910-30

Bismuth Subsalicylate

525 mg/30 mL

Upset stomach reliever/Antidiarrheal

FOR INSTITUTIONAL USE ONLY

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-0910
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-0910-40	4 in 1 CASE	07/17/2020
1		10 in 1 TRAY
1	NDC: 0121-0910-30	30 mL in 1 CUP, UNIT-DOSE; 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	07/17/2020

Labeler - Pharmaceutical Associates, Inc. (044940096)

Registrant - Pharmaceutical Associates, Inc. (097630693)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		097630693	label(0121-0910) , manufacture(0121-0910)