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NDC 63629-8853-01 Ibuprofen Oral 100 mg/5mL Details

Ibuprofen Oral 100 mg/5mL

Ibuprofen Oral is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is IBUPROFEN.

MedlinePlus Drug Summary

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 63629-8853-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen

Product Information

NDC	63629-8853
Product ID	63629-8853_9b4b103d-fdd4-4686-ae72-6197ab1f4616
Associated GPIs	66100020001820
GCN Sequence Number	012080
GCN Sequence Number Description	ibuprofen ORAL SUSP 100 MG/5ML ORAL
HIC3	S2B
HIC3 Description	NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
GCN	35930
HICL Sequence Number	003723
HICL Sequence Number Description	IBUPROFEN
Brand/Generic	Generic
Proprietary Name	Ibuprofen Oral
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ibuprofen Oral
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/5mL
Substance Name	IBUPROFEN
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210602
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63629-8853-01 (63629885301)

Pricing Information	N/A
NDC Package Code	63629-8853-1
Billing NDC	63629885301
Package	1 BOTTLE in 1 CARTON (63629-8853-1) / 118 mL in 1 BOTTLE
Marketing Start Date	2019-09-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3762ee9b-5811-46e2-83df-db5f6863e055 Details

ACTIVE INGREDIENT(S)

(in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USE(S)

temporarily:

relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
reduces fever

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 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

if the child has ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

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

Ask a doctor or pharmacist before use if the child is

under a doctor's care for any serious condition
taking any other drug

WHEN USING THIS PRODUCT

take with food or milk if stomach upset occurs

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

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)

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) under 24 24-35 lbs 36-47 lbs 48-59 lbs 60-71 lbs 72-95 lbs	Age (yr) under 2 years 2-3 years 4-5 years 6-8 years 9-10 years 11 years	Dose (mL)* ask a doctor 5 mL 7.5 mL 10 mL 12.5 mL 15 mL

*or as directed by a doctor

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

Berry flavor (with dye)

Acesulfame 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.

Berry flavor (dye free)

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.

Grape flavor

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Red #33, FD&C Blue #1, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.

Bubble Gum flavor

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.

QUESTIONS SECTION

Call 1-888-588-1418 from 9 AM to 5 PM EST,

Monday-Friday.

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA

HOW SUPPLIED

NDC: 63629-8853-1: 118 mL in a BOTTLE

PRINCIPAL DISPLAY PANEL

Ibuprofen Suspension Dye Free Berry #118

INGREDIENTS AND APPEARANCE

IBUPROFEN ORAL

ibuprofen oral suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-8853(NDC:69230-311)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63629-8853-1	1 in 1 CARTON	09/18/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210602	09/18/2019

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-8853) , RELABEL(63629-8853)

Revised: 4/2022

Document Id: 9b4b103d-fdd4-4686-ae72-6197ab1f4616

Set id: 3762ee9b-5811-46e2-83df-db5f6863e055

Version: 102

Effective Time: 20220427