Stomach Relief by AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 Drug Facts

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief by is a Otc medication manufactured, distributed, or labeled by AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOMACH RELIEF ORIGINAL STRENGTH- bismuth subsalicylate liquid 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385

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 15 mL, 1 tablespoon)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

  • upset stomach
  • heartburn
  • indigestion
  • diarrhea
  • nausea

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:

  • taking other salicylate products
  • allergic to salicylates (including aspirin)

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 right away. (1-800-222-1222)

Directions

  • shake well before using
  • mL = milliliter; TBSP = tablespoon
  • use the enclosed dosing cup designed for use with this product, or tablespoon (TBSP)
  • adults and children 12 years and over
    • 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed
    • do not exceed 8 doses (240 mL or 16 TBSP) 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 tablespoon contains: sodium 15 mg
  • sugar free
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)

Total salicylate per tablespoon 130 mg

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?

1-866-534-4631

Principal Display Panel

*Compare to the active ingredient in Original Pepto-Bismol®

Stomach Relief

ORIGINAL STRENGTH

Bismuth Subsalicylate 525 mg

Upset Stomach Reliever/Antidiarrheal

Soothing relief for 5 symptoms:

  • Upset Stomach
  • Indigestion
  • Heartburn
  • Diarrhea
  • Nausea

FL OZ (mL)

*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.

Distributed by:

AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

www.goodneighborpharmacy.com

Package Label

Bismuth subsalicylate 262 mg

Good Neighbor Pharmacy Stomach Relief

STOMACH RELIEF  ORIGINAL STRENGTH
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 24385-302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg  in 15 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: 24385-302-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/06/201312/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33505/06/201312/31/2019
Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 (007914906)

Revised: 11/2019
Document Id: 3e96f9be-aaa9-46a0-a7fd-67b5685661e4
Set id: ea908cbc-e409-4398-bf3c-7ae7cc6adda1
Version: 3
Effective Time: 20191108
 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385