Ibuprofen infants Drops

Manufacturer
Harris Teeter, LLC
Effective date
2025-02-04
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:22

Label at a glance#

ProductIbuprofen infants Drops
Active ingredientIBUPROFEN
Label structure15 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 find right dose on chart below. If possible, use weight to dose; otherwise use age. mL=milliliter measure with dosing device provided. Do not use any other dosing device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6-8 hours do not...

Storage and handling

store between 20-25 o C (68-77 o F) do not use if carton is opened or if printed neckband is imprinted with "SEALED FOR YOUR PROTECTION" and "USE WITH ENCLOSED DOSING DEVICE ONLY" is broken or missing.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each 1.25 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, USP 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USE(S)

INDICATIONS & USAGE SECTION

temporarily:


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

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 you 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

OTC - DO NOT USE SECTION

  • 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

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, 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

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

  • take with food or milk if stomach upset occurs

STOP USE AND ASK 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
  • child has symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of the 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

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
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • mL=milliliter
  • measure with dosing device provided. Do not use any other dosing device.
  • dispense liquid slowly into the child's mouth, toward the inner cheek
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day

Dosing Chart


WEIGHT (lb) AGE (mos) DOSE (mL) 
 under 6 mos
 
 ask a doctor
12-17 lbs 6-11 mos 1.25 mL
 18-23 lbs 12-23 years 1.875 mL



OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store between 20-25oC (68-77oF)
  • do not use if carton is opened or if printed neckband is imprinted with "SEALED FOR YOUR PROTECTION" and "USE WITH ENCLOSED DOSING DEVICE ONLY" is broken or missing.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

QUESTIONS OR COMMENTS?

SPL UNCLASSIFIED SECTION

call 1-609-860-2600 (Monday - Friday 8:00 am - 4:30 pm EST)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Motrin® Infants' Drops Dye-Free*

Harris Teeter™

NDC 69256-687-09

For Ages 6 mos. to 23 mos.
Infants' Concentrated Drops
Ibuprofen
Oral Suspension
50 mg per 1.25 mL
PAIN RELIEVER/FEVERREDUCER (NSAID)


Dye-Free

  

  • Lasts up to 8 Hours
  • Use Only With Enclosed Syringe
  • Non-Staining


Berry Flavor
1 FL OZ (30 mL)

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637-o.jpg637-o.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSN2
204442ibuprofen 40 MG/ML Oral SuspensionSCD2
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSY2
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69256-687-09Ibuprofen infants Drops1 in 1 CARTONSUSPENSION/ DROPS12
69256-687-09Ibuprofen infants Drops30 mL in 1 BOTTLESUSPENSION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-687IBUPROFEN INFANTS DROPS (IBUPROFEN) SUSPENSION/ DROPS [HARRIS TEETER, LLC]2Current NDC, 2 package rows20250206_2c39a24f-4e42-d75f-e063-6394a90a60fa.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69256-68769256-687-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210755-001IBUPROFENIBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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2026-08-18 06:07:402026-07A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-263f01610625f2…
2019-09-15 20:21 UTC2019-09A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210755-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2018-09-26f41ea6bd6efb…

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
Ibuprofen infants DropsIBUPROFENHarris Teeter, LLC2c39a24f-4e42-d75f-e063-6394a90a60fa2025-02-04WarningsExact identifier
ndc (package): 69256-687-09
ndc (product): 69256-687
ndc11 (package): 69256068709
spl id: 24638320-f647-4dff-954c-8ae49197746a
spl set id: 2c39a24f-4e42-d75f-e063-6394a90a60fa

Reported adverse events (FAERS/openFDA)#

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