LEADER SINUS CONGESTION AND PAIN DAYTIME NON DROWSY - acetaminophen and phenylephrine hydrochloride tablet, film coated
Cardinal Health

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.

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Active ingredient (in each caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Nasal decongestant

Uses

for the temporary relief of:
headache
sinus congestion and pressure
nasal congestion
minor aches and pains
helps decongest sinus openings and passages
promotes sinus drainage
helps clear nasal passages

Warnings

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

more than 12 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

Ask a doctor before use if you have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

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

you get nervous, dizzy or sleepless
pain or nasal congestion 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

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.

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 Liver warning)

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 12 caplets in 24 hours
children under 12 years	do not use this adult product in children under 12 years of age

Inactive ingredients

acesulfame potassium, carnauba wax, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warnings Information

Compare to Tylenol® Sinus Congestion & Pain active ingredients

Sinus Congestion & Pain

Daytime Non-Drowsy

Contains 2 Medicines:

Pain Reliever – Acetaminophen

Nasal Decongestant – Phenylephrine HCl

Headache Pain

Sinus Pressure

Nasal Congestion

Instant Cooling Sensation

Cool Ice®

Sinus Congestion & Pain Carton

LEADER SINUS CONGESTION AND PAIN DAYTIME NON DROWSY
acetaminophen, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-571
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM
CARNAUBA WAX
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
POVIDONE
STEARIC ACID
TALC
TITANIUM DIOXIDE
CROSPOVIDONE

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL (caplet, film-coated)	Size	16mm
Flavor		Imprint Code	L272
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37205-571-62	2 BLISTER PACK ( BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		12 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (37205-571-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/15/1990

Labeler - Cardinal Health (097537435)

Revised: 09/2009 Cardinal Health