CHILDRENS NOVEX IBUPROFEN- ibuprofen suspension 
Herbion Pakistan (Pvt.) Ltd

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Active ingredient

(in each 5 mL = 1 teaspoonful)

Ibuprofen 100mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose:

Pain reliever/ fever reducer

Uses:

temporarily:

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

■ reduces fever

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

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 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 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 or Comments?

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

Childrens novex ibuprofen.jpg

CHILDRENS NOVEX IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44237-041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColororangeScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44237-041-021 in 1 CARTON03/18/202003/27/2020
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02051603/18/202003/27/2020
Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)
Registrant - Herbion Pakistan (Pvt.) Ltd (645482936)
Establishment
NameAddressID/FEIBusiness Operations
Herbion Pakistan (Pvt.) Ltd645482936manufacture(44237-041)

Revised: 2/2021
 
Herbion Pakistan (Pvt.) Ltd