Childrens Novufen Ibuprofen

Manufacturer
NOVUGEN PHARMA LLC
Effective date
2020-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:23:16

Label at a glance#

ProductChildrens Novufen Ibuprofen
Active ingredientIBUPROFEN
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

(in each 5 mL = 1 teaspoonful)

Ibuprofen 100mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose:

Pain reliever/ fever reducer

INDICATIONS & USAGE SECTION

Uses:

temporarily:

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

■ reduces fever

WARNINGS SECTION

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.

OTC - ASK DOCTOR SECTION

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

OTC - DO NOT USE SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

Questions or Comments?

Call +998954752030 OR +998954762030

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 78307-100-01

Children's
Novufen
Ibuprofen

Ibuprofen
Oral Suspension (NSAID)
100 mg / 5 mL

Pain Reliever / Fever Reducer

Lasts up to
8 hours Alcohol Free

2-11 years Orange Flavor 4 fl oz (120 mL)

120 ml label120 ml label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78307-10078307-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020516-001CHILDREN'S MOTRINIBUPROFEN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16
N020516-002MOTRIN IBIBUPROFEN200MG/10MLSUSPENSION / ORALRLD, RS2026-07-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-1684e616aacf4f…
2026-09-14 22:38:342026-08N020516-002MOTRIN IB200MG/10MLSUSPENSION / ORALRLD, RS2026-07-2284e616aacf4f…
2026-08-18 06:07:402026-07N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07N020516-002MOTRIN IB200MG/10MLSUSPENSION / ORALRLD, RS2026-07-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-163f01610625f2…
2019-09-15 20:21 UTC2019-09N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-163bdfa0b2c4d7…

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
bdaa8cea-60c2-fcce-e053-2a95a90a236fa974aa0e-2e01-2c7d-e053-2a95a90a57d92021-03-16WarningsExact identifier
spl set id: a974aa0e-2e01-2c7d-e053-2a95a90a57d9

Reported adverse events (FAERS/openFDA)#

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