LEADER CHILDRENS PAIN AND FEVER- acetaminophen suspension 
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 5 mL = 1 teaspoon)

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 has ever had an allergic reaction to this product or any of its ingredients

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

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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical 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 Liver warning)
shake well before using
find right dose on chart. If possible, use weight to dose; otherwise, use age.
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give for more than 5 days unless directed by a doctor

Weight(lb)

Age(yr)

Dose (tsp or mL)

under 24

under 2 years

ask a doctor

24-35

2–3 years

1 tsp or 5 mL

36–47

4–5 years

1 1/2 tsp or 7.5 mL

48–59

6–8 years

2 tsp or 10 mL

60-71

9–10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 mL

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

Other information

each teaspoon contains: sodium 3 mg
store at 20-25°C (68-77°F)
do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children’s Tylenol® Oral Suspension active ingredient

For Ages 2 to 11

CHILDREN’S

Pain & Fever

Suspension Liquid

Acetaminophen Oral Suspension

80 mg per ½ teaspoon (160 mg per 5 ml)

Pain Reliever/Fever Reducer

Bubble Gum Flavor

Aspirin Free

Ibuprofen Free

Alcohol Free

Children's Pain and Fever Carton Image 1
Children's Pain and Fever Carton Image 2
LEADER CHILDRENS PAIN AND FEVER 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-016
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
CALCIUM SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
CARRAGEENAN 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SODIUM PHOSPHATE, TRIBASIC 
Product Characteristics
ColorRED (opaque) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-016-041 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/22/1997
Labeler - Cardinal Health (097537435)

Revised: 04/2013
 
Cardinal Health