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healthy accents childrens multi symptom fever and cold

Medically reviewed on July 13, 2017

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL, CHLORPHENIRAMINE MALEATE 1mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: DZA Brands LLC
NDC Code: 55316-005

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.

DZA Brands, LLC Children’s Multi-Symptom Fever & Cold Drug Facts

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses
temporarily relieves
minor aches and pains
headache
minor sore throat pain
runny nose
itchy nose or throat
sneezing
itchy, watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold
temporarily reduces fever

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
in a child under 4 years of age
if your child has ever had an allergic reaction to this product or any of its ingredients
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
to make a child sleepy

Ask a doctor before use if your child has
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a breathing problem such as chronic bronchitis
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use your child is

taking

sedatives or tranquilizers
the blood thinning drug warfarin

When using this product
do not exceed recommended dosage
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop use and ask a doctor if
nervousness, dizziness or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. 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). Prompt 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
remove the child protective cap and squeeze your child’s dose into the dosing cup
may be given every 4-6 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.

Age

Dose

children under 4

years of age

do not use

children 4 to under 6

years of age

do not use unless directed by a doctor

children 6 to under 12 years of age

10 mL

Other information
each 5 mL contains: sodium 3 mg
contains no aspirin
store at 20-25°C (68-77°F). Protect from light.
close cap tightly

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Children’s Triaminic® Suspension Multi-Symptom Fever & Cold active ingredients

children’s multi - symptom fever & cold

acetaminophen (pain reliever/fever reducer)

chlorpheniramine maleate (antihistamine)

dextromethorphan HBr (cough suppressant)

phenylephrine HCl (nasal decongestant)

triacting suspension

cold & flu symptom relief

runny & stuffy nose

aches & pains

fever – cough

sore throat

for ages 6 to under 12 years

grape flavor

4 FL OZ (118mL)

alcohol free – aspirin free

NO GLUTEN

HEALTHY ACCENTS CHILDRENS MULTI SYMPTOM FEVER AND COLD 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARRAGEENAN 
D&C RED NO. 33 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
ANHYDROUS CITRIC ACID 
CALCIUM SULFATE 
SODIUM PHOSPHATE, TRIBASIC 
Product Characteristics
ColorPURPLE (opaque) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55316-005-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/22/2015
Labeler - DZA Brands LLC (090322194)

 
DZA Brands LLC

Further information

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

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