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NDC 70000-0439-01 Leader Stomach Relief 525 mg/30mL Details

Leader Stomach Relief 525 mg/30mL

Leader Stomach Relief is a ORAL LIQUID 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: 70000-0439-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	70000-0439
Product ID	70000-0439_b015fc01-5c3f-4bda-9df2-442831acace9
Associated GPIs	47300010001805
GCN Sequence Number	002858
GCN Sequence Number Description	bismuth subsalicylate ORAL SUSP 262MG/15ML ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	26970
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	LIQUID
Route	ORAL
Active Ingredient Strength	525
Active Ingredient Units	mg/30mL
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 70000-0439-01 (70000043901)

Pricing Information	N/A
NDC Package Code	70000-0439-1
Billing NDC	70000043901
Package	118 mL in 1 BOTTLE (70000-0439-1)
Marketing Start Date	2019-06-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 517ff62b-4cad-4cff-90b3-c63c1cab47b3 Details

ACTIVE INGREDIENT(in each 30 mL)

Bismuth subsalicylate 525 mg

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 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
bloody or black stool
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 immediately.

DIRECTIONS

shake well before use
mL = milliliter
TBSP = tablespoon
adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
do not exceed 8 doses (16 TBSP or 240 mL) 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 caused by diarrhea

OTHER INFORMATION

each 30 mL or 2 TBSP contains:
potassium 25 mg
salicylate 260 mg
sodium 8 mg
protect from freezing
avoid excessive heat (over 104oF or 40oC)
dosage cup provided

INACTIVE INGREDIENTS

benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0439-2

Stomach Relief

Bismuth Subsalicylate, 525 mg

Upset Stomach Reliever/Anti-diarrheal

5 Symptom Digestive Relief:

Diarrhea, Heartburn, Indigestion, Nausea & Upset Stomach

COMPATE TO PEPTO-BISMOL active ingredient*

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

LEADER STOMACH RELIEF

bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0439
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0439-2	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/07/2019
2	NDC:70000-0439-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/07/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part335	06/07/2019

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

Revised: 1/2022

Document Id: b015fc01-5c3f-4bda-9df2-442831acace9

Set id: 517ff62b-4cad-4cff-90b3-c63c1cab47b3

Version: 4

Effective Time: 20220110