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Dye-Free Childrens Acetaminophen Grape

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: P & L Development, LLC
NDC Code: 49580-3444

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.

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
DYE-FREE CHILDRENS ACETAMINOPHEN GRAPE 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-3444
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49580-3444-4118 mL in 1 BOTTLE, PLASTIC
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: 01/2017
 
P & L Development, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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