CHILDRENS NOVEX IBUPROFEN- ibuprofen suspension

Childrens Novex Ibuprofen by

Drug Labeling and Warnings

Childrens Novex Ibuprofen 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 = 1 teaspoonful)

Ibuprofen 100mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose:

Pain reliever/ fever reducer

INDICATIONS & USAGE

Uses:

temporarily:

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

■ reduces fever

WARNINGS

Warnings

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

■ hives

■ shock

■ asthma (wheezing)

■ rash

■ skin reddening

■ blisters

■ facial swelling

If an allergic reaction occurs. stop use and seek medical help right away.

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the child:
■ has had stomach ulcers or bleeding problems
■ takes a blood thinning (anticoagulant) or steroid drug
■ takes other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or Other)
■ takes more or for a longer time than directed

Sore throat warning:
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

ASK DOCTOR

Ask a doctor before use if
■ stomach bleeding warning applies to your child
■ child has a history of stomach problems, such as heartburn
■ chid has problems or serious side effects from taking pain relievers or fever reducers
■ child has not been drinking fluids
■ child has lost a lot of fluid due to vomiting or diarrhea
■ child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
■ child has asthma
■ child is taking a diuretic

Ask a doctor or pharmacist before use if the child is
■ under a doctor’s care for any serious condition

■ taking any other drug

When using this product
■ take with food or milk if stomach upset occurs

■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and ask a doctor if
■ child experiences any of the following signs of stomach bleeding
feels faint vomits blood has bloody or black stools has stomach pain that does not get better
■ the child does not get any relief within the first day (24 hours) of treatment

■ fever or pain gets worse or lasts more than 3 days

■ redness or swelling is present in the painful area

■ any new symptoms appear

DO NOT USE

Do not use
■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgery

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION

Directions
■ this product does not contain directions or complete warnings for adult use

■ do not give more than directed

■ mL= milliliter; tsp=teaspoonful

■ shake well before using

■ find right dose on chart. If possible, use weight to dose; otherwise use age.

■ use only enclosed dosing syringe or cup

■ if needed, repeat dose every 6-8 hours

■ do not use more than 4 times a day

■ replace original bottle cap to maintain child resistance

                                             Dosing Chart

Weight (lb)	Age (yr)	Dose (tsp or mL)*
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL (1 tsp)
36-47 lbs	4-5 years	7.5 mL (1 ⅟2 tsp)
48-59 lbs	6-8 years	10 mL (2 tsp)
60-71 lbs	9-10 years	12.5 mL (2 ⅟2 tsp)
72-95 lbs	11 years	15 mL (3 tsp)

*or as directed by a doctor

OTHER SAFETY INFORMATION

Other information

■ each 5 mL (1tsp) contains: sodium 1.755 mg

■do not use if bottle cap seal is broken

■ store between 68-77°F (20-25°C)
■ see bottom panel for lot number and expiration date

INACTIVE INGREDIENT

Inactive Ingredients:

Aspartame, Citric Acid, FD&C Yellow 6, Flavor, Polysorbate 80, Potassium Sorbate, Silicon Dioxide, Sodium Benzoate, Sodium Saccharin, Sorbitol, Sucrose, Water, Xanthan Gum

QUESTIONS

Questions or Comments?

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

NDC:

44237-041-02 Children's NovexIbuprofen IbuprofenOral Suspension (NSAID)100 mg / 5 mL Pain Reliever / Fever Reducer Lasts up to8 hours Alcohol Free 2-11 years Orange Flavor 4 fl oz (120 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS NOVEX IBUPROFEN 
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-041
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ASPARTAME (UNII: Z0H242BBR1)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-041-02	1 in 1 CARTON	03/18/2020
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
NDA	NDA020516	03/18/2020

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(44237-041)