NDC | 63868-776-04, 63868-779-04, 63868-779-08 |
Set ID | c156af97-31df-4152-9331-874df1387073 |
Category | HUMAN OTC DRUG LABEL |
Packager | QUALITY CHOICE (Chain Drug Marketing Association) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA074916 |
- Drug Facts
- Active ingredient
- Purpose
- Uses
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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
▪ blistersIf 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 the child is
- When using this product
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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
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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)* 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 - Other information
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Inactive ingredients
Grape: acesulfame potassium, artificial grape flavor, citric acid anhydrous, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum
Original Berry: acesulfame potassium, citric acid anhydrous, D&C yellow #10, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum
Dye-Free Berry: acesulfame potassium, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum
Bubble Gum: acesulfame potassium, artificial bubble gum flavor, citric acid anhydrous, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
QC®
QUALITY
CHOICENDC 63868-776-04
†Compare to the active ingredient in CHILDREN’S MOTRIN® GRAPE
See New Warnings
For Ages 2 to 11 years
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mLPain Reliever
Fever ReducerLasts up to 8 hours
Alcohol Free
Shake Well Before UsingGrape Flavor
4 FL OZ (118mL)
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PRINCIPAL DISPLAY PANEL
QC®
QUALITY
CHOICENDC 63868-779-04
†Compare to the active ingredient in CHILDREN’S MOTRIN® BERRY
See New Warnings
For Ages 2 to 11 years
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mLPain Reliever
Fever ReducerLasts up to 8 hours
Alcohol Free
Shake Well Before UsingOriginal
Berry Flavor4 FL OZ (118mL)
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PRINCIPAL DISPLAY PANEL
QC®
QUALITY
CHOICENDC 63868-724-04
†Compare to the Active Ingredient in Children's Motrin® Dye-Free Berry
See New Warnings
For Ages 2 to 11 years
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mLPain Reliever
Fever ReducerLasts up to 8 hours
Alcohol Free
Shake Well Before UsingNon-Staining
Dye-Free
Berry Flavor4 fl oz (118 mL)
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PRINCIPAL DISPLAY PANEL
QC®
QUALITY
CHOICENDC 63868-709-04
†Compare to the Active Ingredient in Children's Motrin® Bubble Gum
See New Warnings
For Ages 2 to 11 years
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mLPain Reliever
Fever ReducerLasts up to 8 hours
Alcohol Free
Shake Well Before UsingBubble Gum
Flavor4 fl oz (118 mL)
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INGREDIENTS AND APPEARANCE
IBUPROFEN CHILDRENS
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-776 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) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-776-04 1 in 1 CARTON 03/22/2018 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 ANDA074916 03/22/2018 IBUPROFEN CHILDRENS
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-779 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) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color ORANGE Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-779-08 1 in 1 CARTON 03/22/2018 1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63868-779-04 1 in 1 CARTON 01/25/2019 2 118 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 ANDA074916 03/22/2018 IBUPROFEN CHILDRENS
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-724 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) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-724-04 1 in 1 CARTON 03/09/2020 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 ANDA074916 03/09/2020 IBUPROFEN CHILDRENS
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-709 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) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) 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:63868-709-04 1 in 1 CARTON 03/09/2020 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 ANDA074916 03/02/2020 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)