CHILDRENS TYLENOL - acetaminophen 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 ingredient (in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

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

this product does not contain directions or complete warnings for adult use.
do not give more than directed (see overdose warning)
shake well before using
mL = milliliter; tsp = teaspoonful
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
remove the child protective cap and squeeze your child's dose into the dosing cup
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL or tsp) *
* or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35	2-3 years	5 mL (1 tsp)
36-47	4-5 years	7.5 mL (1½ tsp)
48-59	6-8 years	10 mL (2 tsp)
60-71	9-10 years	12.5 mL (2½ tsp)
72-95	11 years	15 mL (3 tsp)

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

Other information

each 5 mL (1 tsp) contains: sodium 2 mg
store between 20-25°C (68-77°F)
do not use if carton is opened or if carton tape or bottle wrap imprinted "Safety Seal®" is broken or missing
see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

See New Directions

NDC 50580-123-50

Children's
TYLENOL®
Acetaminophen
Oral Suspension
Pain Reliever-Fever Reducer

PAIN & FEVER
Ages 2-11

Ibuprofen Free
Alcohol Free
Aspirin Free

Cherry
Blast
FLAVOR

4 fl oz (120 ml)
160 mg per 5 ml

CHILDRENS TYLENOL
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50580-123
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
acetaminophen (acetaminophen)	acetaminophen	160 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid
butylparaben
FD&C red No. 40
glycerin
high fructose corn syrup
cellulose, microcrystalline
carboxymethylcellulose sodium
propylene glycol
water
sodium benzoate
sorbitol
sucralose
xanthan gum

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY (Blast)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50580-123-01	1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
1		30 mL in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50580-123-01)
2	NDC:50580-123-02	1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
2		60 mL in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50580-123-02)
3	NDC:50580-123-03	1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
3		120 mL in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50580-123-03)
4	NDC:50580-123-04	1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
4		120 mL in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50580-123-04)
5	NDC:50580-123-50	1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
5		120 mL in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50580-123-50)
6	NDC:50580-123-51	1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
6		120 mL in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50580-123-51)
7	NDC:50580-123-52	1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
7		60 mL in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50580-123-52)
8	NDC:50580-123-53	1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
8		30 mL in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50580-123-53)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/01/2011

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

Revised: 11/2011 McNeil Consumer Healthcare Div. McNeil-PPC, Inc