AVEREX- childrens acetaminophen oral suspension suspension

Averex by

Drug Labeling and Warnings

Averex by is a Otc medication manufactured, distributed, or labeled by A-Z Pharma Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WHEN USING

When using this product do not exceed recommended dose (see overdose warning)

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

ASK DOCTOR

Ask a doctor before use if your child has liver disease.

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 20-25ºC (68-77ºF)
■ 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

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

INGREDIENTS AND APPEARANCE

AVEREX 
childrens acetaminophen oral suspension suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83314-111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83314-111-11	1 in 1 CARTON	03/14/2023
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/14/2023

Labeler - A-Z Pharma Group LLC (124947702)