careone childrens ibuprofen

Manufacturer: American Sales Company
Effective date: 2025-08-30
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:12:17

Label at a glance#

Productcareone childrens ibuprofen

Active ingredientIBUPROFEN

Label structure9 sections

Indications and uses

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

Dosage and administration

• chew or crush tablets completely before swallowing • this product does not contain directions or complete warnings for adult use • do not give more than directed • find right dose on chart below. 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) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47...

Storage and handling

• phenylketonurics: contains phenylalanine 6 mg per tablet • store between 20-25 ° C (68-77 ° F) • do not use if printed seal under cap is broken or missing

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

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:

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 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

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

mouth or throat burning may occur; give with food or water
take with food or milk if stomach upset occurs

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
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

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

chew or crush tablets completely before swallowing
this product does not contain directions or complete warnings for adult use
do not give more than directed
find right dose on chart below. 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)	Tablets
under 24	under 2	ask a doctor
24-35	2-3	1
36-47	4-5	1 ½
48-59	6-8	2
60-71	9-10	2 ½
72-95	11	3

Other information

STORAGE AND HANDLING SECTION

phenylketonurics: contains phenylalanine 6 mg per tablet
store between 20-25^°C (68-77^°F)
do not use if printed seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREone^®

For Ages 2 to 11

Children’s

IBUPROFEN Chewable Tablets, 100 mg

Compare to the active ingredient in Children’s Motrin^®

Pain Reliever/Fever Reducer (NSAID)

Orange-Flavored Chewables

Chew or crush tablets completely before swallowing

Lasts up to 8hrs

Actual Size

24 TABLETS

careone-childrens-ibuprofen-orange-carton-image.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310963	ibuprofen 100 MG Chewable Tablet	PSN	4
310963	ibuprofen 100 MG Chewable Tablet	SCD	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
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
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-740-62	careone childrens ibuprofen	24 in 1 BOTTLE	TABLET, CHEWABLE	24		4
41520-740-62	careone childrens ibuprofen	1 in 1 CARTON	TABLET, CHEWABLE	1		4

Products#

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

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

careone childrens ibuprofen
ibuprofen
ACESULFAME POTASSIUM
AMMONIUM GLYCYRRHIZATE
ASPARTAME
CARNAUBA WAX
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6 ALUMINUM LAKE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SOYBEAN OIL
SUCCINIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41520-740	41520-740-62

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
AMMONIUM GLYCYRRHIZATE	3VRD35U26C	IACT
ASPARTAME	Z0H242BBR1	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C YELLOW NO. 6 ALUMINUM LAKE	GYP6Z2JR6Q	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SOYBEAN OIL	241ATL177A	IACT
SUCCINIC ACID	AB6MNQ6J6L	IACT

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076359-001	IBUPROFEN	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL			2004-01-16
A076359-002	IBUPROFEN	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL		RS	2004-01-16

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`74a2ff9319b5…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
careone childrens ibuprofen	IBUPROFEN	American Sales Company	bf88f91c-70ed-42be-b79c-ec60d4f0acda	2025-08-30	Warnings	Exact identifier ndc (package): 41520-740-62 ndc (product): 41520-740 ndc11 (package): 41520074062 spl id: abf6140f-e0f5-4034-aec8-15ca8acc5d0b spl set id: bf88f91c-70ed-42be-b79c-ec60d4f0acda

Reported adverse events (FAERS/openFDA)#

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