FDA.reportPublic FDA data

Leader Adult Tussin Mucus and Chest Congestion 541

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER | Guardian Drug Company
Effective date
2024-09-20
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:58

Label at a glance#

ProductLeader Adult Tussin Mucus and Chest Congestion 541
Active ingredientGUAIFENESIN
Label structure13 sections

Dosage and administration

shake well before using  do not take more than 6 doses in any 24-hour period  measure only with dosing cup provided keep dosing cup with product  ml=milliliter this adult product is not intended for use in children under 12 years of age Age  Dose  adults & children  12 years & over  10 mL to 20 mL every 4 hours  children under 12 years  ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 200 mg 

PURPOSE

OTC - PURPOSE SECTION

Expectorant

USE(S)

INDICATIONS & USAGE SECTION

  • helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes

WARNINGS

WARNINGS SECTION

.

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

  • cough that occurs with too much phlegm(mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 

IF PREGNANT OR BREAST-FEEDING,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

shake well before using 

do not take more than 6 doses in any 24-hour period 

measure only with dosing cup provided

keep dosing cup with product 

ml=milliliter

this adult product is not intended for use in children under 12 years of age

Age Dose
 adults & children  12 years & over 10 mL to 20 mL every 4 hours
 children under 12 years ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • each 10 mL contains: sodium 12 mg 
  • store at 20-25oC(68-77oF)
  • protect from light

INACTIVE INGRADIENTS

INACTIVE INGREDIENT SECTION

caramel color, citric acid anhydrous, FD&C red# 40 dye, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate.  

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

(609) 860-2600

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER TM

NDC70000-0696-1

Adult Tussin

Mucus + Chest Congestion

Guaifenesin, USP 200 mg per 10 mL

Expectorant

Cherry Flavor 

For Ages 12 and Over

Loosens and Relieves Mucus and 

Chest Congestion

100% Money Back Guarantee

4FL OZ(118 mL)

541-4oz-ldr-o.jpg
541-4oz-ldr-o.jpg

541-4oz-ldr-x.jpg541-4oz-ldr-x.jpg


LEADER TM

NDC70000-0696-2

Adult Tussin

Mucus + Chest Congestion

Guaifenesin, USP 200 mg per 10 mL

Expectorant

Cherry Flavor 

For Ages 12 and Over

Loosens and Relieves Mucus and 

Chest Congestion

100% Money Back Guarantee

8FL OZ (237 mL)

541-8oz-ldr-o.jpg541-8oz-ldr-o.jpg

541-8oz-ldr-x.jpg541-8oz-ldr-x.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1606850guaiFENesin 200 MG in 10 mL Oral SuspensionPSN1
1606850guaifenesin 20 MG/ML Oral SuspensionSCD1
1606850guaifenesin 200 MG per 10 ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0696-1Leader Adult Tussin Mucus and Chest Congestion 541118 mL in 1 BOTTLELIQUID1181
70000-0696-1Leader Adult Tussin Mucus and Chest Congestion 5411 in 1 CARTONLIQUID11
70000-0696-2Leader Adult Tussin Mucus and Chest Congestion 541237 mL in 1 BOTTLELIQUID2371
70000-0696-2Leader Adult Tussin Mucus and Chest Congestion 5411 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0696LEADER ADULT TUSSIN MUCUS AND CHEST CONGESTION 541 (GUAIFENESIN) LIQUID [CARDINAL HEALTH 110, LLC. DBA LEADER]1Current NDC, 4 package rows20240922_d7fae410-9c1c-4231-9fde-2c51ad3d7e95.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0696-1ML - Milliliter70000-069644710a7e-f55d-4b69-9471-e0b5957d721512025-10-14
70000-0696-2ML - Milliliter70000-0696d2e80e9a-1023-4243-b96f-ba44776f0aed12025-05-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-069670000-0696-1, 70000-0696-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARAMELT9D99G2B1RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Adult Tussin Mucus and Chest Congestion 541GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADERd7fae410-9c1c-4231-9fde-2c51ad3d7e952024-09-20WarningsExact identifier
ndc (package): 70000-0696-1
ndc (package): 70000-0696-2
ndc (product): 70000-0696
ndc11 (package): 70000069601
ndc11 (package): 70000069602
spl id: d7fae410-9c1c-4231-9fde-2c51ad3d7e95
spl set id: d7fae410-9c1c-4231-9fde-2c51ad3d7e95

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.