Label: IBUPROFEN ORAL- ibuprofen oral suspension
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NDC Code(s):
70677-1115-1,
70677-1115-2,
70677-1116-1,
70677-1117-1, view more70677-1118-1
- Packager: Strategic Sourcing Services
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 17, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
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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
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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
- WHEN USING THIS PRODUCT
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STOP USE AND ASK 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
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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 resistanceDosing Chart
Weight (lb) Age (yr) Dose (mL)*
Weight (lb) Age (yr) Dose (mL)*
Weight (lb) Age (yr) Dose (mL)*
under 24 under 2 years ask a doctor
under 24 under 2 years ask a doctor
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL
24-35 lbs 2-3 years 5 mL
24-35 lbs 2-3 years 5 mL
36-47 lbs 4-5 years 7.5 mL
36-47 lbs 4-5 years 7.5 mL
36-47 lbs 4-5 years 7.5 mL
48-59 lbs 6-8 years 10 mL
48-59 lbs 6-8 years 10 mL
48-59 lbs 6-8 years 10 mL
60-71 lbs 9-10 years 12.5 mL
60-71 lbs 9-10 years 12.5 mL
60-71 lbs 9-10 years 12.5 mL
72-95 lbs 11 years 15 mL
72-95 lbs 11 years 15 mL
72-95 lbs 11 years 15 mL
*or as directed by a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENT
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QUESTIONS or COMMENTS?
Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
©2023 McKesson Corporation
Distributed by:McKesson Corp., via Strategic Sourcing Services LLC.
Memphis, TN 38141
Money Back Guarantee
www.fosterandthrive.com
**This product is not manufactured or distributed by McNeil
Consumer Healthcare, distributor of Children’s Motrin ®. -
PRINCIPAL DISPLAY PANEL
ibuprofen-oral-suspension-berry-flavor-container-carton-118 mL
ibuprofen-oral-suspension-berry-original-flavor-container-carton-237 mL
ibuprofen-oral-suspension-bubble-gum-flavor-container-carton-118 mL
ibuprofen-oral-suspension-grape-flavor-container-carton-118 mL
ibuprofen-oral-suspension-original-berry-flavor-container-carton-118 mL
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INGREDIENTS AND APPEARANCE
IBUPROFEN ORAL
ibuprofen oral suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1115 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1115-1 1 in 1 CARTON 08/09/2023 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70677-1115-2 1 in 1 CARTON 08/09/2023 2 237 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210602 08/09/2023 IBUPROFEN ORAL
ibuprofen oral suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1116 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 purple Score Shape Size Flavor BERRY (original berry flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1116-1 1 in 1 CARTON 08/09/2023 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210602 08/09/2023 IBUPROFEN ORAL
ibuprofen oral suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1117 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1117-1 1 in 1 CARTON 08/09/2023 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210602 08/09/2023 IBUPROFEN ORAL
ibuprofen oral suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1118 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1118-1 1 in 1 CARTON 08/09/2023 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210602 08/09/2023 Labeler - Strategic Sourcing Services (116956644) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(70677-1115, 70677-1116, 70677-1117, 70677-1118)