Harmon Stores Inc. Children’s Ibuprofen Oral Suspension Drug Facts

Manufacturer
Harmon Stores Inc.
Effective date
2021-11-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:26:45

Label at a glance#

Productharmon face values ibuprofen
Active ingredientIBUPROFEN
Label structure9 sections

Indications and uses

temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever

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; tsp = teaspoonful • 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 origina...

Storage and handling

• each 5 mL (1 tsp) contains: sodium 2 mg • do not use if printed neckband is broken or missing • store at 20-25°C (68-77°F) • do not freeze • see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL = 1 teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

Warnings

WARNINGS SECTION

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

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

OTC - DO NOT USE SECTION

  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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, or kidney disease
  • child has asthma
  • child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • give 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

OTC - STOP USE SECTION

  • 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 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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • mL = milliliter; tsp = teaspoonful
  • 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
  • wash dosage cup after each use

Dosing Chart

Weight (lb)

Age (yr)

Dose (mL or tsp)**

under 24 lbs

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 (1½ tsp)

48-59 lbs

6-8 years

10 mL (2 tsp)

60-71 lbs

9-10 years

12.5 mL (2½ tsp)

72-95 lbs

11 years

15 mL (3 tsp)

**or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL (1 tsp) contains: sodium 2 mg
  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare Ours to the Active Ingredient in Children’s Motrin®

For Ages 2 to 11 Years

Children’s Ibuprofen

Oral Suspension

100 mg per 5 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 Hours

Berry Flavor

Dosage Cup Provided

ALCOHOL FREE

GLUTEN FREE

4 FL OZ (118 mL)

Harmon Face Values Children's Ibuprofen Image 1
Harmon Face Values Children's Ibuprofen Image 1
Harmon Face Values Children's Ibuprofen Image 2
Harmon Face Values Children's Ibuprofen Image 2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM1
IBUPROFENACTIVE MOIETYWK2XYI10QM1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-89763940-897-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 7 · 411 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / VAGINAL0.4 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRASYNOVIAL0.2 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / SUBCUTANEOUS25 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HEMULSION / OPHTHALMIC26 mgExact identifier — unii candidate
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
31 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, EXTENDED RELEASE / ORAL119.7 mgExact identifier — unii candidate
27 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii candidate
28 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / SUBCUTANEOUS101 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSPRAY / NASAL0.01 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii candidate
61 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii candidate
27 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS35 mgExact identifier — unii candidate
61 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, COATED / ORAL2.5 mgExact identifier — unii candidate
31 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / BUCCAL0.01 mgExact identifier — unii candidate
28 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRACARDIAC25 mgExact identifier — unii candidate
61 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSOAP / TOPICAL1.4 %w/wExact identifier — unii candidate
31 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSYSTEM / TOPICAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates

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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074937-001CHILDREN'S IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22c2088c7a36db…
2026-09-14 22:38:342026-08A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223a93d1ddd44b…

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
13da3447-2f45-44b4-b660-70101abe2f1714b8890d-237a-4203-bc4c-c08df4441ba62021-11-18WarningsExact identifier
spl id: 13da3447-2f45-44b4-b660-70101abe2f17
spl set id: 14b8890d-237a-4203-bc4c-c08df4441ba6

Reported adverse events (FAERS/openFDA)#

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