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Goodsense Regular strength Stomach Relief 122

Good sense  Regular strength stomach relief 122

Approved
Approval ID

f0588ab8-d1fc-419a-8d68-bee42332d50f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

Preferred Pharmaceuticals Inc.

DUNS: 791119022

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bismuth Subsalicylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68788-4002
Application NumberM008
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bismuth Subsalicylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (6)

BISMUTH SUBSALICYLATEActive
Quantity: 262 mg in 1 1
Code: 62TEY51RR1
Classification: ACTIB
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

PRINCIPAL DISPLAY PANEL

OODSENSE** ®**

Regular Strength

NDC 50804-152-49

Stomach Relief Tablets

Bismuth Subsalicylate 262 mg

Antidiarrheal/Upset Stomach Reliever

Soothing Relief For

5 Symptoms

**Upset Stomach**

**Indigestion**

**Heartburn**

**Nausea**

**Diarrhea**

Actual Size

*** Compare to active ingredient of Pepto-Bismol****®**** Chewable Tablets**

30 Chewable Tablets

NDC 68788-4002-3

Relabeled By: Preferred Pharmaceuticals Inc.

Bismuth Subsalicylate Tablets 262mg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

USE(S)

relieves:

diarrhea 

heartburn 

indigestion 

nausea

upset stomach associated with these symptoms 

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

ACTIVE INGREDIENT(S)

Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

PURPOSE

Upset stomach reliever and anti-diarrheal

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

INACTIVE INGRADIENTS

calcium carbonate, D&C red 27 aluminum lake, flavor, Magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

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

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/1/2025

DO NOT USE

if you have

bloody or black stool

an ulcer

a bleeding problem

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/1/2025

ASK A DOCTOR BEFORE USE IF YOU HAVE

fever

mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 8/1/2025

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

taking any drug for

anticoagulation (thinning of the blood)

diabetes

gout

arthritis

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/1/2025

WHEN USING THIS PRODUCT

a temporary, but harmless darkening of the stool and/or tongue may occur.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

STOP USE AND ASK DOCTOR IF

symptoms get worse 

ringing in the ears or loss of hearing occurs

diarrhea lasts more than 2 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 8/1/2025

IF PREGNANT OR BREAST-FEEDING,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

DIRECTIONS

chew or dissolve in mouth 

adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed 

do not take more than 8 doses (16 tablets) in 24 hours

children under 12 years: ask a doctor 

drink plenty of clear fluids to help prevent dehydration caused by diarrhea 

use until diarrhea stops but not more than 2 days

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/1/2025

OTHER INFORMATION

each tablet contains:

sodium less than 1 mg 

salicylate 102 mg

very low sodium 

avoid excessive heat (over 104oF or 40oC).

**TAMPER EVIDENT: Do not use if individual compartments are torn or open.**

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Goodsense Regular strength Stomach Relief 122 - FDA Drug Approval Details