HEALTHY ACCENTS CHILDRENS MULTI SYMPTOM FEVER AND COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
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 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
Uses
- •
- temporarily relieves
- •
- minor aches and pains
- •
- headache
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- minor sore throat pain
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- 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.
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
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 |
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| Labeler - DZA Brands LLC (090322194) |