Children's Ibuprofen Oral Suspension

Children's Ibuprofen Oral Suspension
SPL v5
SPL
SPL Set ID f0959369-890e-403e-8a98-4eda340a0783
Route
ORAL
Published
Effective Date 2020-12-16
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 D&c Red No. 33 Fd&c Red No. 40 Glycerin Microcrystalline Cellulose Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sucrose Xanthan Gum

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-12-15

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

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  11years  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

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

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 for 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

   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

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

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

Section 51945-4

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

res

Section 53413-1

Questions or comments?

Call 732-314-4550 from 9AM to 5PM EST,

Monday - Friday.

Section 55105-1

Purpose

Ibuprofen .... Pain reliever/fever reducer

Section 55106-9

Active ingredient

(in each 5 mL)

Ibuprofen 100 mg (NSAlD)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

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


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  11years  15 mL

* or as directed by a doctor

Warnings and Precautions (34071-1)

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.

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)

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

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 for 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

   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

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

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

Section 51945-4 (51945-4)

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

res

Section 53413-1 (53413-1)

Questions or comments?

Call 732-314-4550 from 9AM to 5PM EST,

Monday - Friday.

Section 55105-1 (55105-1)

Purpose

Ibuprofen .... Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient

(in each 5 mL)

Ibuprofen 100 mg (NSAlD)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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