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infants fever reducer and pain reliever

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Rite Aid Corporation
NDC Code: 11822-0590

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.

Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts

Active ingredient (in each 5 mL)

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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: 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. Insert syringe tip into bottle opening.
flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
pull yellow part of 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 20-25ºC (68-77ºF)
do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

SEE NEW WARNINGS

Compare to the active ingredient of Infants’ Tylenol® Oral Suspension

infants’

fever reducer & pain reliever

acetaminophen 160 mg/5 mL

oral suspension

DYE-FREE

non-staining formula

alcohol free

aspirin free

ibuprofen free

gluten-free

cherry flavor

for ages 2-3 years

use only enclosed syringe

2 FL OZ (59 mL)

see side panel for more information

INFANTS FEVER REDUCER AND PAIN RELIEVER 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0590
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 
CALCIUM SULFATE 
CARRAGEENAN 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
SODIUM PHOSPHATE, TRIBASIC 
Packaging
#Item CodePackage Description
1NDC:11822-0590-11 BOTTLE in 1 CARTON
159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/08/1993
Labeler - Rite Aid Corporation (014578892)

 
Rite Aid Corporation

← See all infants fever reducer and pain reliever brands

Medically reviewed on Aug 28, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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