CAREONE PAIN RELIEF INFANTS- 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 Pain Relief Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purposes

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
find right dose on chart. If possible, use weight to dose; otherwise, use age.
push air out of syringe. Firmly push syringe into bottle opening.
turn bottle upside down. Pull syringe to the first dose line and then push product back into bottle.
pull syringe until it reaches and stays at the correct dose
dispense liquid slowly into child’s mouth, toward inner cheek
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

*or as directed by a doctor

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

Other Information

store at 20-25°C (68-77°F)
do not use if printed bottle wrap is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, 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?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the Active Ingredient in Infants’ Tylenol® Oral Suspension

INFANTS’

PAIN RELIEF

Fever Reducer - Pain Reliever

Acetaminophen

Suspension Liquid

GRAPE FLAVOR

Alcohol Free – Aspirin Free

Ibuprofen Free

See side panel for more information

Use only with enclosed syringe

See New Dosage & Directions

1 FL OZ (30mL)

160 mg per 5 mL

CareOne Infants' Pain Relief Image 1
CareOne Infants' Pain Relief Image 2
CAREONE PAIN RELIEF  INFANTS
acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-946
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-946-10 1 in 1 CARTON
1 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 09/02/2011
Labeler - American Sales Company (809183973)

Revised: 3/2014
Document Id: 442019f1-4c62-453d-89c3-c7600411d6b9
Set id: f6c02c6e-0866-4003-a2d3-21d023d62e5c
Version: 2
Effective Time: 20140317
 
American Sales Company