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
- Pharmaceutical Associates, Inc.
- Effective date
- 2018-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:03:42
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. if needed repeat dose every 6–8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Dose (mL) **or as directed by a doctor Under 24 lbs under 2 years ask a doctor 24–35 ...
Storage and handling
each 5 mL contains: sodium 2 mg store at 20° to 25°C (68° to 77°F) do not freeze Children's Ibuprofen Oral Suspension is an orange, berry flavored suspension supplied in the following oral dosage form: NDC 0121-1836-05: 5 mL unit dose cup. Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each.
Contacts and useful links#
Websitewww.paipharm.com
www.paipharm.com
www.paipharm.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL)
Purposes
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
- give 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 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
- shake well before using
- mL = milliliter
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- if needed repeat dose every 6–8 hours
- do not use more than 4 times a day
| Weight (lb) | Age (yr) | Dose (mL) |
|---|---|---|
| **or as directed by a doctor | ||
| Under 24 lbs | 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 |
Other information
- each 5 mL contains: sodium 2 mg
- store at 20° to 25°C (68° to 77°F)
- do not freeze
Children's Ibuprofen Oral Suspension is an orange, berry flavored suspension supplied in the following oral dosage form:
| NDC 0121-1836-05: | 5 mL unit dose cup. Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each. |
Inactive ingredients
anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum.
Questions or comments?
Call 1-800-845-8210. You may also report serious side effects to this phone number.
SPL UNCLASSIFIED SECTION
Gluten Free
DISTRIBUTED BY
MAJOR PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
PACKAGED BY
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharm.com
R12/17
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
Delivers
5 mL
NDC 0121-1836-05
CHILDREN'S IBUPROFEN
O
RAL
SUSPENSION
(NSAID)
100 mg per 5 mL (teaspoon)
SHAKE WELL
Alcohol Free
FOR INSTITUTIONAL USE ONLY
Pkg. by: Pharmaceutical Associates, Inc.
Greenville, SC 29605
SEE INSERT
A18360502
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | Code 128 | (01)00301211836052 | GTIN-14: 00301211836052 GTIN-12: 301211836052 UPC-A: 301211836052 EAN-13: 0301211836052 GTIN storage (14 digits): 00301211836052 | ibuprofen-01.jpg |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0121-1836-05 | 2023-10-13 | C162847 | 48780-1 | d6a99b39-d045-a426-e053-dadaa90af4c2 | Children's Ibuprofen |
| 0121-1836-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d045-a426-e053-dadaa90af4c2 | Children's Ibuprofen |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-1836-05 | ML - Milliliter | 0121-1836 | 87fdadb7-1770-4abb-9e6c-b5f07b36b007 | 1 | 2015-04-03 |
| 0904-5309-09 | ML - Milliliter | 0904-5309 | 84c04695-1074-42e6-acd5-1135fa49faa9 | 1 | 2012-07-24 |
| 0904-5309-20 | ML - Milliliter | 0904-5309 | 8ae6ee02-bad4-4150-bfb7-98614da02dd7 | 1 | 2013-02-11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| Ibuprofen | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Childrens Ibuprofen
- Ibuprofen
- SODIUM BENZOATE
- HIGH FRUCTOSE CORN SYRUP
- XANTHAN GUM
- SORBITOL
- ANHYDROUS CITRIC ACID
- D&C YELLOW NO. 10
- FD&C RED NO. 40
- GLYCERIN
- HYPROMELLOSE, UNSPECIFIED
- POLYSORBATE 80
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0121-1836 | 0121-1836-05 |
| 0904-5309 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SORBITOL | 506T60A25R | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION / ORAL | 20 mg/5ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| Polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / ORAL | 206 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg |
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 |
|---|---|---|---|---|---|---|---|
| A074937-001 | CHILDREN'S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 |
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 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | Major Pharmaceuticals | 847758ed-66fc-4db9-8fdb-78f3c3291a03 | 2026-01-26 | Warnings | 0904-5309 |
| 6fabdb67-0edb-407e-ab85-40131165f40d | d7fc559e-8cd3-4f31-9a89-150ad97eb890 | 2023-10-13 | Warnings | d7fc559e-8cd3-4f31-9a89-150ad97eb890 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.