Mucus Relief Chest Congestion

Manufacturer
Cardinal Health | LNK International, Inc.
Effective date
2021-02-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:49:59

Label at a glance#

ProductMucus Relief Chest Congestion
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years of age and over 1 to 2 tablets every 4 hours children 6 to under 12 years of age ½ to 1 tablet every 4 hours children under 6 years of age consult a physician

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) use by expiration date on package

Label contents#

Full prescribing information#

Active ingredient (in each immediate-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
adults and children 12 years
of age and over
1 to 2 tablets every
4 hours
children 6 to under 12 years
of age

½ to 1 tablet every
4 hours

children under 6 years of ageconsult a physician

Other information

STORAGE AND HANDLING SECTION

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0251-1

Mucus Relief
Chest Congestion

Guaifenesin, 200 mg
Expectorant

For Relief Of:
Chest Congestion
Thins and Loosens Mucus
Immediate Release

60
TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313

100% Money Back Guarantee
Return to place of purchase if not satisfied.

50844     ORG081258811

CIN 5316948

Leader 44-588
Leader 44-588

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0251-1EA - Each70000-02518eb858ad-7225-42b2-9776-c25d075e8a7b12017-11-06

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-025170000-0251-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
a323a341-f41a-4ab3-8388-505b31690e35c78b7464-782d-4787-a5cd-9abc9b5c8de02021-02-26WarningsExact identifier
spl id: a323a341-f41a-4ab3-8388-505b31690e35
spl set id: c78b7464-782d-4787-a5cd-9abc9b5c8de0

Reported adverse events (FAERS/openFDA)#

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