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NDC 70677-0150-02 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 Strategic Sourcing Services. 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: 70677-0150-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen

Product Information

NDC	70677-0150
Product ID	70677-0150_e5e79c54-bf94-3d7d-e053-2995a90a3812
Associated GPIs
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	Strategic Sourcing Services
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	2024-12-31

Package

Package Images

NDC 70677-0150-02 (70677015002)

Pricing Information
NDC Package Code	70677-0150-2
Billing NDC	70677015002
Package	1 BOTTLE in 1 CARTON (70677-0150-2) / 237 mL in 1 BOTTLE
Marketing Start Date	2022-08-01
NDC Exclude Flag	N
Price Per Unit	0.03113
Pricing Unit	ML
Effective Date	2024-01-17
NDC Description	SM CHILD IBUPROFEN 100 MG/5 ML
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL a3062142-db0e-4758-a762-2b2bb05670b1 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 833-358-6431 Mon - Fri 9 AM to 7 PM EST.

Distributed by: McKesson Corp.,

via Strategic Sourcing Services LLC.,

Memphis, TN 38141

PRINCIPAL DISPLAY PANEL

Ibuprofen oral suspension berry flavour with dye container carton

Ibuprofen oral suspension berry flavour with dye free container carton

Ibuprofen oral suspension grape flavour container carton

Ibuprofen oral suspension bubble gum flavour container carton

INGREDIENTS AND APPEARANCE

IBUPROFEN ORAL

ibuprofen oral suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0150
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 (UNII: K679OBS311)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CELLULOSE, MICROCRYSTALLINE (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	orange	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-0150-1	1 in 1 CARTON	08/01/2022
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:70677-0150-2	1 in 1 CARTON	08/01/2022
2		237 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	11/23/2018

IBUPROFEN ORAL

ibuprofen oral suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0153
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 (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-0153-1	1 in 1 CARTON	08/01/2022
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	08/01/2022

IBUPROFEN ORAL

ibuprofen oral suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0152
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 (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-0152-1	1 in 1 CARTON	08/01/2022
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	08/01/2022

IBUPROFEN ORAL

ibuprofen oral suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0151
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 (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE (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:70677-0151-1	1 in 1 CARTON	08/01/2022
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	08/01/2022

Labeler - Strategic Sourcing Services (116956644)

Name	Address	ID/FEI	Business Operations
Establishment
AptaPharma Inc.		790523323	manufacture(70677-0150, 70677-0151, 70677-0152, 70677-0153)

Revised: 8/2022

Document Id: e5e79c54-bf94-3d7d-e053-2995a90a3812

Set id: a3062142-db0e-4758-a762-2b2bb05670b1

Version: 1

Effective Time: 20220810

Search by Drug Name or NDC

NDC 70677-0150-02 Ibuprofen Oral 100 mg/5mL Details

Ibuprofen Oral 100 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70677-0150-02 (70677015002)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a3062142-db0e-4758-a762-2b2bb05670b1 Details

ACTIVE INGREDIENT(S)

PURPOSE

USE(S)

WARNINGS

DO NOT USE

ASK A DOCTOR BEFORE USE IF

Ask a doctor or pharmacist before use if the child is

WHEN USING THIS PRODUCT

Stop use and ask a doctor if

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

Other information

INACTIVE INGREDIENT SECTION

QUESTIONS SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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