TYLENOL SINUS CONGESTION AND PAIN- acetaminophen and phenylephrine hydrochloride tablet, coated
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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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TYLENOL®
SINUS
CONGESTION AND PAIN

Important: Read all product information before using. Keep this box for important information.

Drug Facts

Active ingredients (in each gelcap)	Purpose
Acetaminophen 325 mg	Pain reliever
Phenylephrine HCl 5 mg	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 gelcaps 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.
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
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 exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
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.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage.

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)

adults and children 12 years and over	take 2 gelcaps every 4 hours do not take more than 12 gelcaps in 24 hours
children under 12 years	do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

store between 20-25°C (68-77°F). Avoid high humidity.
do not use if carton is opened or if blister unit is broken
see side panel for lot number and expiration date

Inactive ingredients

benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, colloidal silicon dioxide, corn starch, D&C yellow #10, edetate calcium disodium, FD&C blue #1, FD&C blue #2, FD&C red #40, gelatin, hypromellose, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, stearic acid, titanium dioxide, yellow iron oxide

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-229-24

See New Warnings Information

TYLENOL®

SINUS
CONGESTION & PAIN

Alleviates Sinus Headache & Pain
Acetaminophen

Relieves Sinus Pressure
Clears Nasal Congestion
Phenylephrine HCl

24 RR GELCAPS

Rapid Release
GELS

DAYTIME
Non-Drowsy

TYLENOL SINUS CONGESTION AND PAIN
acetaminophen and phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:50580-229
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (Acetaminophen)	Acetaminophen	325 mg
Phenylephrine hydrochloride (Phenylephrine)	Phenylephrine hydrochloride	5 mg

Ingredient Name	Strength
Inactive Ingredients
benzyl alcohol
ferrosoferric oxide
butylparaben
carboxymethylcellulose sodium
silicon dioxide
starch, corn
D&C yellow NO. 10
edetate calcium disodium
FD&C Blue NO. 1
FD&C Blue NO. 2
FD&C red NO. 40
gelatin
hypromelloses
methylparaben
cellulose, microcrystalline
polyethylene glycols
polysorbate 80
powdered cellulose
propylene glycol
propylparaben
ferric oxide red
sodium lauryl sulfate
sodium propionate
sodium starch glycolate type a potato
stearic acid
titanium dioxide
ferric oxide yellow

Product Characteristics
Color	RED, GREEN (Red and green with gray subcoat band)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	TY;S;CP
Contains

#	Item Code	Package Description
Packaging
1	NDC:50580-229-02	2500 in 1 TRAY
1		2 in 1 POUCH; Combination Product Type = C112160
2	NDC:50580-229-24	2 in 1 CARTON
2		12 in 1 BLISTER PACK; Combination Product Type = C112160
3	NDC:50580-229-48	4 in 1 CARTON
3		12 in 1 BLISTER PACK; Combination Product Type = C112160
4	NDC:50580-229-72	1 in 1 CARTON
4		72 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/01/2007	04/13/2012

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 1/2015

Document Id: 066969a0-9ea9-4b72-a7c6-d1424b86eb6a

Set id: e5942d0d-7252-4bd9-95cf-d7c9950a6383

Version: 3

Effective Time: 20150114

McNeil Consumer Healthcare Div McNeil-PPC, Inc

TYLENOL® SINUS CONGESTION AND PAIN