Stomach Relief by Western Family Foods, Inc. Drug Facts

Stomach Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

STOMACH RELIEF MAXIMUM STRENGTH- bismuth subsalicylate liquid 
Western Family Foods, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each 30 mL)

Bismuth subsalicylate 1050 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • fullness
    • 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

  • a sodium-restricted diet
  • 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
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL (1 dose) every 1 hour as needed
    • do not take more than 4 doses (120 mL) in 24 hours
    • use until diarrhea stops but not more than 2 days
  • children under 12 years of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

  • each 30 mL contains: sodium 19mg
  • each 30 mL contains: salicylate 455 mg
  • sugar free
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)

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 1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

Maximum Strength

Stomach Relief

Soothing Relief of:

  • UPSET STOMACH
  • INDIGESTION
  • NAUSEA
  • HEARTBURN
  • DIARRHEA

Bismuth subsalicylate 1050 mg

Upset Stomach Reliever & Antidiarrheal

FL OZ (mL)

COMPARE TO PEPTO-BISMOL® active ingredient*

Gluten Free

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

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

Proudly Distributed by Western Family Food, Inc.

P.O. Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Package Label

Bismuth Subsalicylate 1050 mg

Western Family Maximum Strength Stomach Relief Liquid

STOMACH RELIEF  MAXIMUM STRENGTH
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55312-071
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE1050 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: 55312-071-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/201512/31/2019
2NDC: 55312-071-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/201512/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33503/31/201512/31/2019
Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018
Document Id: f747cd11-582d-47bb-9d56-c24c7b670e0b
Set id: 22fccb2d-f0a8-4f00-9d60-81039ce4984d
Version: 4
Effective Time: 20181228
 
Western Family Foods, Inc.