Label: CHILDRENS IBUPROFEN- ibuprofen suspension
- NDC Code(s): 63868-795-04, 63868-795-08
- Packager: Chain Drug Marketing Association, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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 directedHeart 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
-
ASK DOCTOR
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 DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
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
-
DOSAGE & 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 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 11years 15 mL * or as directed by a doctor
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
PRINCIPAL DISPLAY PANEL
children's
ibuprofen
Oral Suspension (NSAID)
For Ages 2 to 11 Years
NDC 63868-795-04
QC
QUALITY CHOICE See New Warnings
Compare to the
active ingredient in
Children's Motrin®children's
ibuprofenOral Suspension (NSAID)
100 mg per 5 mLPain Reliever/Fever Reducer
8 HRS Lasts up to
8 HoursFor ages 2 to 11 years
Alcohol FreeOriginal Berry
Flavor4 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-117
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-23624 OZ
8 OZ
res
-
INGREDIENTS AND APPEARANCE
CHILDRENS IBUPROFEN
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-795 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) FD&C RED NO. 40 (UNII: WZB9127XOA) 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 orange Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-795-04 1 in 1 CARTON 12/15/2020 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63868-795-08 1 in 1 CARTON 12/15/2020 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 12/15/2020 Labeler - Chain Drug Marketing Association, Inc. (011920774) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(63868-795)