NDC 78307-100 Childrens Novufen Ibuprofen

Ibuprofen

NDC Product Code 78307-100

NDC 78307-100-01

Package Description: 1 BOTTLE in 1 CARTON > 120 mL in 1 BOTTLE

NDC Product Information

Childrens Novufen Ibuprofen with NDC 78307-100 is a a human over the counter drug product labeled by Novugen Pharma Llc. The generic name of Childrens Novufen Ibuprofen is ibuprofen. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Novugen Pharma Llc

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Childrens Novufen Ibuprofen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • IBUPROFEN 100 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

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

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Novugen Pharma Llc
Labeler Code: 78307
FDA Application Number: NDA020516 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-03-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Childrens Novufen Ibuprofen Product Label Images

Childrens Novufen Ibuprofen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredient(in each 5 mL = 1 teaspoonful)Ibuprofen 100mg (NSAID)**nonsteroidal anti-inflammatory drug

Otc - 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

WarningsAllergy 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 swellingIf 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.

Otc - 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 drugWhen 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

Otc - 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

Otc - 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 24under 2 yearsask a doctor24-35 lbs2-3 years5 mL (1 tsp)36-47 lbs4-5 years7.5 mL (1 ⅟2 tsp)48-59 lbs6-8 years10 mL (2 tsp)60-71 lbs9-10 years12.5 mL (2 ⅟2 tsp)72-95 lbs11 years15 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

Otc - Questions

Questions or Comments?Call +998954752030 OR +998954762030

* Please review the disclaimer below.