Children's Ibuprofen Oral Suspension, Dye-free

Children's Ibuprofen Oral Suspension, Dye-free
SPL v2
SPL
SPL Set ID bb995c57-a2cc-4bc7-9c7d-f885c425be64
Route
ORAL
Published
Effective Date 2023-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Carboxymethylcellulose Sodium Glycerin Microcrystalline Cellulose Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sucrose Xanthan Gum

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-09-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

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 for 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 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.

Indications and Usage

Uses temporarily:

■ relieves minor aches and pains due to the common cold, flu, sore throat,

   headache and toothache  ■ reduces fever

Dosage and Administration

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50566-9

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

Section 50567-7

When using this product

■ take with food or milk if stomach upset occurs

Section 50568-5

Ask a doctor or pharmacist before use if the child is

■ under a doctor's care lor any serious condition

■ taking any other drug

Section 50569-3

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

Section 50570-1

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

Section 51727-6

Inactive ingredients

Acesullame potassium, anhydrous citric acid,

carboxymethylcellulose sodium, flavors, glycerin, microcrystalline

cellulose, polysorbate 80, propylene glycol, purified water, sodium

benzoate, sucrose, and xanthan gum

Section 53413-1

Questions or comments?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Section 55105-1

Purpose

Pain reliever/

fever reducer

Section 55106-9

Active ingredient

(in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

■ each 5 mL contains: sodium 2 mg

■ store between 20-2S° C (68-77° F)

■ do not use if printad neckband is broken or missing

Package Labeling: Children's Ibuprofen Oral Suspension Original Berry Flavor

See New Warnings                          NDC 76281-128-24      

AP Safe     

Compare To The

Active Ingredient In

Children’s Motrin®**

For Ages 2 to 11 Years

Children's Ibuprofen

Oral Suspension (NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer

Dye-Free

LASTS UP TO 8 HOURS

Original Berry Flavor

4 FL OZ (118 mL)

Important Read all product information before using.

Keep this box for important infomation.

This product is intended for use in children.

** This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Children’s Motrin®​.

Manufacrured by:

APTAPHARMA Inc.

1533 Union Avenue

Pennsauken, NJ 08110, USA

Carton Label

Bottle Label

res


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily:

■ relieves minor aches and pains due to the common cold, flu, sore throat,

   headache and toothache  ■ reduces fever

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

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

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 for 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 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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

■ take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is

■ under a doctor's care lor any serious condition

■ taking any other drug

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

Acesullame potassium, anhydrous citric acid,

carboxymethylcellulose sodium, flavors, glycerin, microcrystalline

cellulose, polysorbate 80, propylene glycol, purified water, sodium

benzoate, sucrose, and xanthan gum

Section 53413-1 (53413-1)

Questions or comments?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Section 55105-1 (55105-1)

Purpose

Pain reliever/

fever reducer

Section 55106-9 (55106-9)

Active ingredient

(in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

■ each 5 mL contains: sodium 2 mg

■ store between 20-2S° C (68-77° F)

■ do not use if printad neckband is broken or missing

Package Labeling: Children's Ibuprofen Oral Suspension Original Berry Flavor

See New Warnings                          NDC 76281-128-24      

AP Safe     

Compare To The

Active Ingredient In

Children’s Motrin®**

For Ages 2 to 11 Years

Children's Ibuprofen

Oral Suspension (NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer

Dye-Free

LASTS UP TO 8 HOURS

Original Berry Flavor

4 FL OZ (118 mL)

Important Read all product information before using.

Keep this box for important infomation.

This product is intended for use in children.

** This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Children’s Motrin®​.

Manufacrured by:

APTAPHARMA Inc.

1533 Union Avenue

Pennsauken, NJ 08110, USA

Carton Label

Bottle Label

res


Advanced Ingredient Data


Raw Label Data

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