Infant and Children Novex Acetaminophen

Manufacturer
Herbion Pakistan (Pvt.) Ltd
Effective date
2020-03-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:39:38

Label at a glance#

ProductInfant and Children Novex Acetaminophen
Active ingredientACETAMINOPHEN
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

Purpose:

fever reducer / Pain reliever

INDICATIONS & USAGE SECTION

Uses:

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

WARNINGS SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
When using this product do not exceed recommended dose (see overdose warning)


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 occur

■ redness or swelling is present

These could be signs of a serious condition.

OTC - DO NOT USE SECTION

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 of the inactive ingredients in this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:

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.

DOSAGE & ADMINISTRATION SECTION

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

■ mL = milliliter; tsp = teaspoonful

■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.
■ remove the child protective cap and use the dosing vial / measuring cup provided
■ repeat dose every 4 hours while symptoms last
■ do not give more than 5 times in 24 hours

Weight (lb)

    Age (yr)

  Dose (mL)*

Under 24

Under 2 years

    Ask a doctor

24-35

2-3 years

5 mL

36-47

4-5 years

7.5 mL

48-59

6-8 years

10 mL

60-71

9-10 years

12.5 mL

72-95

11 years

15 mL

*or as directed by a doctor

Attention: use only enclosed dosing devices provided, specifically designed for use with this product.

GENERAL PRECAUTIONS SECTION

Other Information

■ each 5 mL (1 tsp) contains: sodium 1.2 mg

■ store between 20-250C (68-770F)

■ do not use if bottle cap seal is broken

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Sucrose, Sorbitol, Glycerin, Flavor, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, FD&C RED NO. 40, Purified Water

OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Infant & Children Novex AcetaminophenInfant & Children Novex Acetaminophen

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44237-04044237-040-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

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
ddb4b2ff-0f6c-4be9-aa40-ec220fe92fe5ca7447ac-5210-4c10-96e8-abb5a488447f2021-07-28WarningsExact identifier
spl set id: ca7447ac-5210-4c10-96e8-abb5a488447f

Reported adverse events (FAERS/openFDA)#

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