PAIN RELIEF INFANTS- acetaminophen suspension/ drops 
Publix Super Markets 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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Publix Super Markets, Inc. Infants' Pain Relief Drug Facts

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Fever reducer/pain reliever

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.

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

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 dropper designed for use with this product. Do not use any other dosing device.
fill to dose level
dispense liquid slowly into child’s mouth, toward inner cheek
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
replace dropper tightly to maintain child resistance
this product does not contain directions or complete warnings for adult use

Dosing Chart

Weight(lb)

Age(yr)

Dose (mL)

under 24

under 2 years

ask a doctor

24-35

2–3 years

1.6 mL (0.8 + 0.8 mL)

Attention: use only enclosed dropper 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, carboxymethylcellulose sodium, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Principal Display Panel

See New Warnings Information

Infants’

Pain Relief

Concentrated Drops

Acetaminophen

80 mg per 0.8 mL

Pain Reliever

Fever Reducer

Cherry Flavor

Compare to Active Ingredient in Concentrated Tylenol® Infants’ Drops

Use Only with Enclosed Dropper

Infant's Pain Relief Carton Image 1

Infants' Pain Relief Carton Image 1

Infant's Pain Relief Carton Image 2

Infants' Pain Relief Carton Image 1

Infants' Pain Relief Carton Image 2

PAIN RELIEF  INFANTS
acetaminophen suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg  in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorRED (opaque) Score    
ShapeSize
FlavorCHERRY (sweet) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-008-051 in 1 CARTON08/18/199303/21/2014
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/18/199303/21/2014
Labeler - Publix Super Markets Inc (006922009)

Revised: 11/2017
 
Publix Super Markets Inc