HEALTHY ACCENTS INFANTS PAIN AND FEVER- acetaminophen liquid 
DZA Brands 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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DZA Brands, LLC Infants' Pain & Fever Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 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.
  • 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

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

  • this product does not contain directions or complete warnings for adult use
  • 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 syringe designed for use with this product. Do not use any other dosing device.
  • remove bottle cap and insert syringe tip through opening at top of the bottle
  • tip the bottle upside down and draw medicine into the syringe
  • 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 cap tightly to maintain child resistance
Dosing Chart
Weight (lb)Age (yr)Dose (mL)
under 24under 2 yearsask a doctor
24-352-3 years5 mL

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, FD&C red no. 40, 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 or comments?

1-866-322-2439

Package/Label Principal Display Panel

PEDIATRICIAN PREFERRED DOSING SYSTEM

SEE NEW DOSAGE & DIRECTIONS

for ages 2 - 3

infants'

pain & fever

acetaminophen

suspension liquid

fever reducer – pain reliever

alcohol free - aspirin free

ibuprofen free - gluten free

Compare to Infants' Tylenol® Suspension Liquid active ingredient

cherry flavor

160mg per 5ml

USE ONLY WITH ENCLOSED SYRINGE

Infants' Pain & Fever Carton Image 1

Infants' Pain & Fever Carton Image 1

Infants' Pain & Fever Carton Image 2

Infants' Pain & Fever Carton Image 2

HEALTHY ACCENTS INFANTS PAIN AND FEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55316-161
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 
BUTYLPARABEN 
CALCIUM SULFATE 
CARRAGEENAN 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SODIUM PHOSPHATE, TRIBASIC 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-161-161 in 1 CARTON
160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/06/2011
Labeler - DZA Brands LLC (090322194)

Revised: 2/2012
 
DZA Brands LLC