CAREONE CHILDRENS PAIN AND FEVER- acetaminophen suspension 
American Sales Company

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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American Sales Company Children’s Pain & Fever 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 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

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 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. 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)*

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 (1 ½ tsp)

48-59

6-8 years

10 mL (2 tsp)

60-71

9-10 years

12.5 mL (2 ½ tsp)

72-95

11 years

15 mL (3 tsp)

*or as directed by a doctor

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 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, 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 the Active Ingredient in Children’s Tylenol® Oral Suspension

CHILDREN’S

PAIN & FEVER

Pain Reliever/Fever Reducer

Acetaminophen

Oral Suspension

160 mg per 5 mL

CHERRY FLAVOR

AGES 2-11

Alcohol Free

Aspirin Free

Ibuprofen Free

4 FL OZ (118 mL)

CareOne Children's Pain & Fever 1.jpg
CareOne Children's Pain & Fever 2.jpg
CAREONE CHILDRENS PAIN AND FEVER 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-404
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 
CARRAGEENAN 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SODIUM PHOSPHATE, TRIBASIC 
Product Characteristics
ColorRED (opaque) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-404-261 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:41520-404-281 in 1 CARTON
2147 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/13/2004
Labeler - American Sales Company (809183973)

Revised: 3/2014
Document Id: 567c9e15-d004-4153-a3c5-49d21b519388
Set id: 6e8b9581-71ab-4956-a488-ff2606ee9778
Version: 2
Effective Time: 20140319
 
American Sales Company