Childrens Ibuprofen Oral Suspension
- Manufacturer
- Discount Drug Mart | AptaPharma Inc.
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:16
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient(in each 5 mL)
Ibuprofen 100 mg (NSAID)
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Usestemporarily:
■ relieves minor aches and pains due to the common cold, flu, sore throat,
headache and toothache
■ reduces fever
WARNINGS SECTION
Warnings
Allergy alertIbuprofen 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
NSAlD, 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 lor a longer time than directed
Heart attack and stroke warning:NSAlDs, 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 lor longer than directed.
Sore throat warning:Severe or persistent sore throat or
sore throat accompanied by high lever, 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
heartbum
■ 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 lor 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
Slop 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 | 11 years | 15 mL |
*or as dIrected by a doctor
OTHER SAFETY INFORMATION
Other information
■
each 5 mL contains:sodium 2 mg
■ store between 20-25° C (68-77° F)
■
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
Acesullame potassium, anhydrous citric acid,
carboxymethylcellulose sodium, D&C Yellow #10, 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 1-877-798-5944 from 9:30 AM to 4:30 PM EST,
Monday-Friday.
Package Labeling
For Ages 2 to 11 Years
DISCOUNT
drug
mart
FOOD FAIR
Children's
Ibuprofen
Oral Suspension (NSAID)
100 mg per 5mL
DISCOUNT
drug
mart
FOOD FAIR
NDC 53943-119-24
Compare To The
Active Ingredient In
Children's Motrin® **
SEE NEW WARNINGS
For Ages 2 to 11 Years
Children's
Ibuprofen
Oral Suspension (NSAID)
100 mg per 5mL
Pain Reliever/Fever reducer
LASTS UP TO 8 HOURS
ALCOHOL FREE
Original Berry Flavor
4 FL OZ (118 mL)
Important: Read all product information 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
®.
SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND
PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO
RETURN TO STORE, SEND REASON FOR DISSATISFACTION,
NAME, ADDRESS, AND EMPTY PACKAGE TO:
DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256
BX-082
0 93351 02962 2
01078436
Box Label
Bottle Label
res
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0093351029622 | GTIN-13: 0093351029622 EAN-13: 0093351029622 GTIN-12: 093351029622 UPC-A: 093351029622 GTIN storage (14 digits): 00093351029622 | DDrugMart 53943-119 Botl.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53943-119-24 | Childrens Ibuprofen Oral Suspension | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 3 | |
| 53943-119-24 | Childrens Ibuprofen Oral Suspension | 1 in 1 CARTON | SUSPENSION | 1 | 3 |
Products#
Every source-derived product name is available through these pages.
- Childrens Ibuprofen Oral Suspension
- IBUPROFEN
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- CARBOXYMETHYLCELLULOSE SODIUM
- D&C YELLOW NO. 10
- FD&C RED NO. 40
- GLYCERIN
- MICROCRYSTALLINE CELLULOSE
- POLYSORBATE 80
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SUCROSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53943-119 | 53943-119-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A210602-001 | IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 |
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.
| 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 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 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 |
|---|---|---|---|---|---|---|
| Childrens Ibuprofen Oral Suspension | IBUPROFEN | Discount Drug Mart | 7b7954b7-e4c8-4284-a649-31a4eb6ba73e | 2025-12-19 | Warnings | 53943-119-24 53943-119 53943011924 465376e9-bf3f-2a69-e063-6294a90a6a4c 7b7954b7-e4c8-4284-a649-31a4eb6ba73e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

