INFANT AND CHILDREN NOVEX ACETAMINOPHEN- acetaminophen suspension

Infant and Children Novex Acetaminophen by

Drug Labeling and Warnings

Infant and Children Novex Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Herbion Pakistan (Pvt.) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

PURPOSE

Purpose:

fever reducer / Pain reliever

INDICATIONS & USAGE

Uses:

temporarily: ■ reduces fever ■ 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 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.

ASK DOCTOR

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.

DO NOT USE

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

KEEP OUT OF REACH OF CHILDREN

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

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

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

Inactive Ingredients:

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

QUESTIONS

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INFANT AND CHILDREN NOVEX ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-040
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
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-040-01	1 in 1 CARTON	03/09/2020
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/09/2020

Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)

Registrant - Herbion Pakistan (Pvt.) Ltd (645482936)

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan (Pvt.) Ltd		645482936	manufacture(44237-040)