Childrens Ibuprofen Oral Suspension

Manufacturer
Chain Drug Marketing Association, Inc. | AptaPharma Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:34

Label at a glance#

ProductChildrens Ibuprofen Oral Suspension
Active ingredientIBUPROFEN
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
(in each 5 mL)
Ibuprofen 100 mg (NSAlD)*
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose
Ibuprofen .... 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 asevere 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.

OTC - DO NOT USE SECTION

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

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
■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is
■ under a doctor's care for any serious condition
■ taking any other drug

OTC - WHEN USING SECTION

When using this product
■ take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

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)

DOSAGE & ADMINISTRATION SECTION

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

Dosing Chart
 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 11years 15 mL

* or as directed by a doctor

OTHER SAFETY INFORMATION

Other information
■ each 5 mL contains: sodium 2 mg
■ store between 20-25ºC (68-77ºF)
■ do not use if carton is opened or printed bottle
  neckband is broken or missing
■ see bottom panel for lot number and expiration date

INACTIVE INGREDIENT SECTION

Inactive ingredients
Acesulfame potassium, anhydrous citric acid,
carboxymethylcellulose sodium, D&C Red #33, FD&C Red
#40, flavors, glycerin, microcrystalline cellulose,
polysorbate 80, propylene glycol, purified water, sodium
benzoate, sucrose, and xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?
Call 732-314-4550 from 9AM to 5PM EST,
Monday - Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

children's

ibuprofen

Oral  Suspension (NSAID)

For Ages 2 to 11 Years

                                             NDC 63868-796-04

QC

QUALITY CHOICE        See New Warnings

Compare to the
active ingredient in
Children's Motrin​®**

children's
ibuprofen

Oral Suspension (NSAID)
100 mg per 5 mL

Pain Reliever/Fever Reducer

8 HRS    Lasts up to
              8 Hours

For ages 2 to 11 years
Alcohol Free

Bubble Gum
Flavor

4 fl oz (118 mL)

Important: Read all product indormation before using
Keep this box for important information.
This product is intended for use in children.

** This product is not manufactured or distributed by McNeil
Consumer Healthcare, distributor of Children's Motrin®.

BX-110

Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

796-04 4OZ796-04 4OZ

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN5
197803ibuprofen 20 MG/ML Oral SuspensionSCD5
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY5
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY5

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
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-796-042022-12-18C16284748780-1d6a99b39-4c8e-a426-e053-dadaa90af4c2Children's Ibuprofen Oral Suspension
63868-796-042022-01-28C16284748780-1d6a99b39-4c8e-a426-e053-dadaa90af4c2Children's Ibuprofen Oral Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-796-04Childrens Ibuprofen Oral Suspension1 in 1 CARTONSUSPENSION15
63868-796-04Childrens Ibuprofen Oral Suspension118 mL in 1 BOTTLESUSPENSION1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-796CHILDRENS IBUPROFEN ORAL SUSPENSION (IBUPROFEN) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION, INC.]5Current NDC, Legacy NDC, 2 package rows20241225_f0959369-890e-403e-8a98-4eda340a0783.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-796-04ML - Milliliter63868-7969339924b-bb26-417c-8e6c-01936059771f12022-09-12

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-79663868-796-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
A210602-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23

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
2026-09-14 22:38:342026-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2384e616aacf4f…
2026-08-18 06:07:402026-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233f01610625f2…
2019-09-15 20:21 UTC2019-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23f41ea6bd6efb…

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
Childrens Ibuprofen Oral SuspensionIBUPROFENChain Drug Marketing Association, Inc.f0959369-890e-403e-8a98-4eda340a07832024-12-23WarningsExact identifier
ndc (package): 63868-796-04
ndc (product): 63868-796
ndc11 (package): 63868079604
spl id: 5c369278-435d-4c67-991c-b4117eb90e4e
spl set id: f0959369-890e-403e-8a98-4eda340a0783

Reported adverse events (FAERS/openFDA)#

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