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#
Contacts and useful links#
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)
Products#
Every source-derived product name is available through these pages.
- Childrens Novufen Ibuprofen
- Ibuprofen
- SUCROSE
- SORBITOL
- SILICON DIOXIDE
- CITRIC ACID MONOHYDRATE
- ASPARTAME
- WATER
- SODIUM BENZOATE
- SACCHARIN SODIUM
- POLYSORBATE 80
- FD&C YELLOW NO. 6
- XANTHAN GUM
- POTASSIUM SORBATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78307-100 | 78307-100-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| SORBITOL | 506T60A25R | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
| XANTHAN GUM | TTV12P4NEE | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020516-001 | CHILDREN'S MOTRIN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | |
| N020516-002 | MOTRIN IB | IBUPROFEN | 200MG/10ML | SUSPENSION / ORAL | RLD, RS | 2026-07-22 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020516-002 | MOTRIN IB | 200MG/10ML | SUSPENSION / ORAL | RLD, RS | 2026-07-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020516-002 | MOTRIN IB | 200MG/10ML | SUSPENSION / ORAL | RLD, RS | 2026-07-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020516-001 | CHILDREN'S MOTRIN | 100MG/5ML | SUSPENSION / ORAL | RLD, RS | 1995-06-16 | 3bdfa0b2c4d7… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| bdaa8cea-60c2-fcce-e053-2a95a90a236f | a974aa0e-2e01-2c7d-e053-2a95a90a57d9 | 2021-03-16 | Warnings | a974aa0e-2e01-2c7d-e053-2a95a90a57d9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
