STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid 
ATLANTIC BIOLOGICALS CORP.

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 dose)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

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

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

Other information

Inactive ingredients

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

Questions or comments?

Call 1-800-645-2158

Distributed by:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16th PLACE

MIAMI, FL 33179

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol®*

Regular Strength

Stomach Relief

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Relieves:

• Heartburn • Indigestion • Nausea

Alcohol Free • Sugar Free

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STOMACH RELIEF  REGULAR STRENGTH
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1286(NDC:0536-1286)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 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)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-1286-150 in 1 BOX, UNIT-DOSE04/28/2022
1NDC:17856-1286-315 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:17856-1286-250 in 1 BOX, UNIT-DOSE04/28/2022
2NDC:17856-1286-430 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33503/29/2020
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-1286)

Revised: 5/2022
Document Id: 029e6183-d03b-4639-98a9-8bf144320a10
Set id: 5c02d0ba-91e4-4bd2-ac66-6905323653b2
Version: 3
Effective Time: 20220519
 
ATLANTIC BIOLOGICALS CORP.