CHILDRENS TYLENOL PLUS FLU - acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride suspension
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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Drug Facts

Active ingredients (in each 5 mL = 1 teaspoon)	Purpose
Acetaminophen 160 mg	Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg	Antihistamine
Dextromethorphan HBr 5 mg	Cough suppressant
Phenylephrine HCl 2.5 mg	Nasal decongestant

Uses

temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough
- stuffy nose
- sneezing and runny nose
temporarily reduces fever

Warnings

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other product containing acetaminophen
to make a child sleepy
in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

heart disease
high blood pressure
thyroid disease
diabetes
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)
a breathing problem such as chronic bronchitis
glaucoma

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

do not exceed recommended dose (see overdose warning)
excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts more than 5 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.

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 give more than directed (see overdose warning)
shake well before using
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
if needed, repeat dose every 4 hours
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (tsp or mL)
under 36	under 4 years	do not use
36-47	4 to 5 years	do not use unless directed by a doctor
48-95	6 to 11 years	2 tsp or 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

store between 20-25°C (68-77°F)
do not use if bottle wrap, or foil inner seal imprinted "Safety Seal®" is broken or missing
see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)

PRINCIPAL DISPLAY PANEL

See New Warnings & Directions

NDC 50580-386-04

Children's
TYLENOL®

Fever Reducer, Pain Reliever,
Cough Suppressant,
Nasal Decongestant,
Antihistamine

Plus

FLU

CONTAINS 4 INGREDIENTS:

Fever & Sore Throat
Acetaminophen
Cough
Dextromethorphan HBr
Stuffy Nose
Phenylephrine HCl
Sneezing &
Runny Nose
Chlorpheniramine
Maleate

BUBBLE
GUM
FLAVOR

4 FL OZ (120mL)

ORAL SUSPENSION

CHILDRENS TYLENOL PLUS FLU
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50580-386
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (acetaminophen)	Acetaminophen	160 mg in 5 mL
Chlorpheniramine Maleate (chlorpheniramine)	Chlorpheniramine Maleate	1 mg in 5 mL
Dextromethorphan Hydrobromide (dextromethorphan)	Dextromethorphan Hydrobromide	5 mg in 5 mL
Phenylephrine Hydrochloride (phenylephrine)	Phenylephrine Hydrochloride	2.5 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid
D&C Red NO. 33
FD&C Red NO. 40
glycerin
cellulose, microcrystalline
carboxymethylcellulose sodium
water
sodium benzoate
sorbitol
sucrose
xanthan gum

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50580-386-04	1 BOTTLE in 1 CARTON	contains a BOTTLE
1		120 mL in 1 BOTTLE	This package is contained within the CARTON (50580-386-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/01/2006	12/31/2011

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

Revised: 01/2013 McNeil Consumer Healthcare Div McNeil-PPC, Inc