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NDC 70000-0440-01 Leader Maximum Strength Stomach Relief 1050 mg/30mL Details

Leader Maximum Strength Stomach Relief 1050 mg/30mL

Leader Maximum Strength 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: 70000-0440-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	70000-0440
Product ID	70000-0440_d6d117a2-ca67-4587-abc6-21e5c13bd8d7
Associated GPIs	47300010001830
GCN Sequence Number	002859
GCN Sequence Number Description	bismuth subsalicylate ORAL SUSP 525MG/15ML ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	26971
HICL Sequence Number	001246
HICL Sequence Number Description	BISMUTH SUBSALICYLATE
Brand/Generic	Generic
Proprietary Name	Leader Maximum Strength 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	1050
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 70000-0440-01 (70000044001)

Pricing Information	N/A
NDC Package Code	70000-0440-1
Billing NDC	70000044001
Package	354 mL in 1 BOTTLE (70000-0440-1)
Marketing Start Date	2019-07-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eac79ee8-0699-4308-b682-ee04a7c7f4c5 Details

ACTIVE INGREDIENT(in each 30 mL)

Bismuth subsalicylate 1050 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 hour as needed
do not exceed 4 doses (8 TBSP or 120 mL) in 24 hours
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

OTHER INFORMATION

each 30 mL or 2 TBSP contains:
potassium 25 mg
salicylate 471 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 70000-0440-1

Maximum Strength

Stomach Relief

Bismuth Subsalicylate, 1050 mg

Upset Stomach Reliever / Antidiarrheal)

COMPARE TO PEPTO-BISMOL ULTRA active ingredient*

5 Symptom Digestive Relief:

Diarrhea, Heartburn, Indigestion, Nausea & Upset Stomach

12 FL OZ (354 mL)

INGREDIENTS AND APPEARANCE

LEADER MAXIMUM STRENGTH STOMACH RELIEF

bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0440
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	1050 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	Marketing End Date
Packaging
1	NDC:70000-0440-1	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part335	07/25/2019

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

Revised: 1/2022

Document Id: d6d117a2-ca67-4587-abc6-21e5c13bd8d7

Set id: eac79ee8-0699-4308-b682-ee04a7c7f4c5

Version: 4

Effective Time: 20220110