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NDC 70000-0433-02 Leader Stomach Relief 262 mg/1 Details

Leader Stomach Relief 262 mg/1

Leader Stomach Relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH 110, LLC. DBA LEADER. The primary component is BISMUTH SUBSALICYLATE.

MedlinePlus Drug Summary

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Related Packages: 70000-0433-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	70000-0433
Product ID	70000-0433_9df0c4ba-19dd-4c07-a1c1-9e9d376bf0f1
Associated GPIs	47300010000507
GCN Sequence Number	002860
GCN Sequence Number Description	bismuth subsalicylate TAB CHEW 262 MG ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	08420
HICL Sequence Number	001246
HICL Sequence Number Description	BISMUTH SUBSALICYLATE
Brand/Generic	Generic
Proprietary Name	Leader Stomach Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/1
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	CARDINAL HEALTH 110, LLC. DBA LEADER
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70000-0433-02 (70000043302)

Pricing Information
NDC Package Code	70000-0433-2
Billing NDC	70000043302
Package	8 BLISTER PACK in 1 BOX (70000-0433-2) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2019-06-06
NDC Exclude Flag	N
Price Per Unit	0.07904
Pricing Unit	EA
Effective Date	2022-07-20
NDC Description	STOMACH RELIEF 262 MG CHEW TAB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-08-03

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 91fbcda6-a068-4ed0-9502-caf395580ad9 Details

ACTIVE INGREDIENT(in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:

diarrhea
heartburn
indigestion
nausea
upset stomach associated with these symptoms

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 behaviour 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

bloody or black stool
an ulcer
a bleeding problem

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

anticoagulation (thinning of the blood)
diabetes
gout
arthritis

WHEN USING THIS PRODUCT

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

STOP USE AND ASK DOCTOR IF

symptoms get worse
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 CHILDREN

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

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
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor
drink plenty of fluids to help prevent dehydration which may accompany diarrhea

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

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

NDC 70000-0433-2

LEADER™

Stomach Relief

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever/Antidiarrheal

5 Symptom Digestive Relief

Diarrhea
Heartburn
Indigestion
Nausea
Upset stomach

COMPATE TO PEPTO-BISMOL® active ingredient*

48 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

LEADER STOMACH RELIEF

bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0433
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	GDC122
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0433-2	8 in 1 BOX	06/06/2019
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70000-0433-1	5 in 1 BOX	06/06/2019
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part335	06/06/2019

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Revised: 1/2022

Document Id: 9df0c4ba-19dd-4c07-a1c1-9e9d376bf0f1

Set id: 91fbcda6-a068-4ed0-9502-caf395580ad9

Version: 3

Effective Time: 20220110