FDA Label for Averex
View Indications, Usage & Precautions
Averex Product Label
The following document was submitted to the FDA by the labeler of this product A-z Pharma Group Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Use
■ 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 nyour 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 ever, 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 is allergic to acetaminophen or any other of
the inactive ingredients in this product.
Otc - When Using
When using this product do not exceed recommended dose (see overdose warning)
Otc - Stop Use
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 ■ redness or swelling is present.
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child
is taking the blood-thinning drug warfarin.
Overdosage
Overdose warning:Taking more than the recommended dose (overdose)
may cause liver damage. In case of overdose, get
medical help or contact a Poison Control Center right
away. (1-800-222-1222) Quick medical attention is critical
for adults as well as for children even if you
do not notice any signs or symptoms.
Directions
■ this product does not contain directions or
complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find the right dose on the chart below. If possible, use
weight to dose, otherwise, use age.
■ 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.
Weight (lb) Age (yr) Dose (mL or tsp)*
under 24 under 2 years ask a doctor
24-35 2 - 3 years 5 mL (1 tsp)
36-47 4 - 5 years 7.5 mL (1 1/2 tsp0
48-59 6 - 8 years 10 mL (2 tsp)
60-71 9 - 10 years 12.5. mL (2 1/2 TSP)
72-95 11 years 15 mL (3 tsp)
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically
designed for use with this product. Do not use any
other dosing device.
Other Information
■ each 5 mL (1 tsp) contains; sodium 3 mg
■ store between 20-25°C (68-77°F)
■ do not refrigerate
■ Keep carton for full directions for use.
Inactive Ingredients
anhydrous citric acid,
Butylparaben, FD&C red #40. Flavor, glycerin. High
Fructose corn syrup, microcrystalline cellulose and
Carboxymethylcellulose sodium, propylene glycol.
Purified water. Sodium benzoate, sorbitol solution.
Sucralose, xanthan gum
Otc - Questions
Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Package Label - Principal Display Panel
Product Label
Children’s Averex
COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN’S TYLENOL
ORAL SUSPENSION*
Pain
& Fever
Acetaminophen
Oral Suspension
Pain reliever/Fever Reducer
• Alcohol-Free
• Ibuprofen Free
• Aspirin Free
• For Ages 2 to 11
4 FL OZ (118 mL)
160 mg per 5 mL
Cherry Flavor
DO NOT USE IF PRINTED NECK BAND IS
BROKEN OR MISSING this
Product is not manufactured or distributed
By McNeil Consumer Healthcare, distributor of
Children’s Tylenol Oral Suspension.
NDC: 83314-111-11
* Please review the disclaimer below.