A-Z Pharma-AptaPharma Acetaminophen Suspension 118 mL

Manufacturer
A-Z Pharma Group LLC
Effective date
2023-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:28

Label at a glance#

ProductAverex
Active ingredientACETAMINOPHEN
Label structure16 sections

Dosage and administration

■ 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) A...

Storage and handling

■ 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.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Use

INDICATIONS & USAGE SECTION

■ relieves minor aches and pains due to:
■ the common cold ■ flu ■ headache ■ sore throat
■ toothache

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

■ 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 SECTION

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

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child

is taking the blood-thinning drug warfarin.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

■ 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

STORAGE AND HANDLING SECTION

■ 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

INACTIVE INGREDIENT SECTION

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 SECTION

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Package Label - Principal Display Panel

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.

AZ-Pharma NDCAZ-Pharma NDC

AZ-Ph-NDCAZ-Ph-NDC

NDC: 83314-111-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN1
307668acetaminophen 32 MG/ML Oral SuspensionSCD1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY1
307668APAP 32 MG/ML Oral SuspensionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83314-111-112025-01-30C16284748780-12cef2736-5d27-d83d-e063-dadaa90ab31fA-Z Pharma-AptaPharma Acetaminophen Suspension 118 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83314-111-11Averex118 mL in 1 BOTTLESUSPENSION1181
83314-111-11Averex1 in 1 CARTONSUSPENSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83314-111AVEREX (CHILDRENS ACETAMINOPHEN ORAL SUSPENSION) SUSPENSION [A-Z PHARMA GROUP LLC]12 package rows20230315_f6e380e4-5101-ad5a-e053-6294a90a4190.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83314-11183314-111-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f6e380e4-5100-ad5a-e053-6294a90a4190f6e380e4-5101-ad5a-e053-6294a90a41902023-03-14WarningsExact identifier
spl id: f6e380e4-5100-ad5a-e053-6294a90a4190
spl set id: f6e380e4-5101-ad5a-e053-6294a90a4190

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.