FDA.reportPublic FDA data

Sinus Congestion and Pain Severe

Manufacturer
Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
Effective date
2022-04-06
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 22:04:13

Label at a glance#

ProductSinus Congestion and Pain Severe Daytime,Non-Drowsy
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache nasal congestion minor aches and pains sinus congestion and pressure temporarily reduces fever helps loosen phlegm (mucus) and the bronchial secretions to make coughs more productive 

Dosage and administration

do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Storage and handling

see end flap for expiration date and lot number TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
  • headache
  • nasal congestion
  • minor aches and pains
  • sinus congestion and pressure
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and the bronchial secretions to make coughs more productive 

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening 

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients 

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 
  • high blood pressure
  • heart disease
  • diabetes
  • thyroid disease
  • liver disease
  • difficulty in urination due to enlargement of the prostate gland 
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole - do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • see end flap for expiration date and lot number
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0196-1

Daytime ι Non-Drowsy

Sinus
Congestion & Pain Severe

Acetaminophen ι Guaifenesin ι Phenylephrine HCl
Pain Reliever/Fever Reducer ι Expectorant ι Nasal Decongestant

Sinus Headache,
Nasal Congestion, Sinus Pressure,
Chest Congestion, Mucus

24 CAPLETS

ACTUAL SIZE

COMPARE TO TYLENOL® SINUS SEVERE
active ingredients* 

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY 
SIGNS OF TAMPERING

CIN 5298153 REV. 11/17

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS SEVERE.

50844    REV0917A52708

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com  1-800-200-6313
Essential to Care™ since 1979

CARDINAL HEALTH, the Cardinal Health LOGO
LEADER, and the Leader LOGO are trademarks or 
registered trademarks of Cardinal Health.

CardinalHealth™

All LEADER™ Brand Products Have A
100% Money Back Guarantee

Return to place of purchase if not satisfied.

Leader 44-527
Leader 44-527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0196-1EA - Each70000-0196d129ed6c-4953-422b-959a-9c2d6e32ee4612018-12-13

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-019670000-0196-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
50d37b80-c82f-41e7-8929-f57411491bc0b42316a2-45dc-4792-af3c-05eab06470fe2022-04-06WarningsExact identifier
spl id: 50d37b80-c82f-41e7-8929-f57411491bc0
spl set id: b42316a2-45dc-4792-af3c-05eab06470fe

Reported adverse events (FAERS/openFDA)#

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