Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

DYE-FREE CHILDRENS ACETAMINOPHEN GRAPE- acetaminophen suspension 
P & L Development, LLC

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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Drug Facts

Active Ingredients

Acetaminophen 160 mg

Purpose

Acetaminophen.............................Pain reliever/fever reducer

Uses

temporarily reduces fever
temporarily 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 non-prescription).
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

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
These could be signs of a serious condition.

Keep this and all drugs out of the reach of children.

Overdose Warning: Taking more than the
recommended dose (overdose) may cause liver
damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control
Center immediately. Quick medical attention is
critical even if you do not notice any signs or
symptoms.

When using this product

do not exceed recommended dose
(see overdose warning)

Directions

this product does not contain directions or
complete warnings for adult use.
shake well before using
find right dose on chart below. 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 more than 5 days unless directed
by a doctor

Weight (lb)                    Age (yr)                       Dose (tsp or mL)
under 24                         under 2                         ask a doctor
24-35                               2-3                                 1 teaspoon or 5 mL
36-47                               4-5                                 1 1/2 teaspoons or 7.5 mL
48-59                               6-8                                 2 teaspoons or 10 mL
60-71                               9-10                               2 1/2 teaspoons or 12.5 mL
72-95                               11                                  3 teaspoons or 15 mL

Other Information

store at controlled room temperature
see bottom panel for lot number and
expiration date

Inactive Ingredients

butyl paraben, carboxymethylcellulose sodium,
cellulose, citric acid, flavors, glycerin, high fructose
corn syrup, propylene glycol, purified water, sodium
benzoate, sorbitol, sucralose, xanthan gum

Principal Display Panel

image of label
DYE-FREE CHILDRENS ACETAMINOPHEN GRAPE 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49580-3444
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49580-3444-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/200907/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/23/200907/31/2019
Labeler - P & L Development, LLC (101896231)

Revised: 1/2017