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Leader Sinus Relief by Cardinal Health

Dosage form: capsule, coated
Ingredients: ACETAMINOPHEN 325mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Cardinal Health
NDC Code: 49781-122

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Cardinal Health Sinus Relief Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Expectorant

Nasal decongestant

Uses
temporarily relieves:
nasal congestion
headache
minor aches and pains
sinus congestion and pressure
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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:

skin reddening
blisters
rash

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

Do not use
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
liver disease
heart disease
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if
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 persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions
do not take more than directed (see overdose warning)
do not take more than 10 caplets in any 24-hour period
adults and children 12 years and older: take 2 caplets every 4 hours
children under 12 years of age: do not use

Other information
each caplet contains: sodium 4 mg
store at 20-25°C (68-77°F)

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C yellow #5 aluminum lake (tartrazine), FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

SEE NEW WARNINGS

For Ages 12+

Compare to Mucinex® Sinus-Max® Pressure & Pain active ingredients

MAXIMUM STRENGTH

Sinus Relief

Acetaminophen – Pain Reliever

Guaifenesin – Expectorant

Phenylephrine HCl – Nasal Decongestant

Pressure & Pain

Relieves Sinus Pressure & Congestion

Relieves Headache

Thins & Loosens Mucus

Actual Size

20 CAPLETS

LEADER SINUS RELIEF 
acetaminophen, guaifenesin, phenylephrine hcl capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-122
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE (15 MPA.S AT 5%) 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-122-2010 BLISTER PACK in 1 CARTON
12 CAPSULE, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/03/2016
Labeler - Cardinal Health (097537435)

 
Cardinal Health

← See all Leader Sinus Relief brands

Medically reviewed on Oct 3, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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