Indications and uses
temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Childrens Ibuprofen
- Manufacturer
- H2-Pharma, LLC
- Effective date
- 2021-12-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:24:13
Label at a glance#
ProductChildrens Ibuprofen
Active ingredientIBUPROFEN
Label structure11 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resist...
Storage and handling
each 5 mL contains: sodium 2 mg store between 20° to 25°C (68° to 77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL)
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
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
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 your child:
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- takes more or for a longer time than directed
Heart attack and stroke warning
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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.
Do not use
- if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- stomach bleeding warning applies to your child
- child has a history of stomach problems, such as heartburn
- child 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, kidney disease, or had a stroke
- 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
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
- child has symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- the child does not get any relief within 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 - 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 (1-800-222-1222) right away.
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- shake well before using
- mL = milliliter
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- use only enclosed dosing cup. Do not use any other dosing device.
- 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
| Weight (lb) | Age (yr) | Dose (mL)* |
|---|---|---|
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
| 36-47 lbs | 4-5 years | 7.5 mL |
| 48-59 lbs | 6-8 years | 10 mL |
| 60-71 lbs | 9-10 years | 12.5 mL |
| 72-95 lbs | 11 years | 15 mL |
* or as directed by a doctor
Other information
- each 5 mL contains: sodium 2 mg
- store between 20° to 25°C (68° to 77°F)
Inactive ingredients
acesulfame potassium, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
SPL UNCLASSIFIED SECTION
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
NDC 61269-761-94
† Compare to the active ingredient
in Children's Motrin®
Children's
Ibuprofen
100 mg per 5 mL
Oral Suspension, USP
(NSAID)
Pain Reliever/Fever Reducer
For ages 2 to 11 years
Shake well before using
Lasts up to 8 hours
Alcohol-free
Dye-free
BERRY FLAVOR
4 fl oz (118 mL)
H2 pharma
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61269-761-94 | ML - Milliliter | 61269-761 | c4feb10d-1447-4bcc-9fbf-63cac5400eb0 | 1 | 2021-07-15 |
Products#
Every source-derived product name is available through these pages.
- Childrens Ibuprofen
- IBUPROFEN
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- GLYCERIN
- POLYSORBATE 80
- STARCH, CORN
- WATER
- SODIUM BENZOATE
- SUCROSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61269-761 | 61269-761-94 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | 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 |
|---|---|---|---|---|---|---|---|
| A074916-001 | IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| d68ede64-6e42-42b2-b25e-4d3bfe1f0c1f | b8ed952d-0c52-4593-9ed7-1f39fa3b1ebe | 2021-12-08 | Warnings | d68ede64-6e42-42b2-b25e-4d3bfe1f0c1f b8ed952d-0c52-4593-9ed7-1f39fa3b1ebe |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.