Target Corporation Concentrated Ibuprofen Oral Suspension Drug Facts

up and up dye free infants concentrated ibuprofen by

Drug Labeling and Warnings

up and up dye free infants concentrated ibuprofen by is a Otc medication manufactured, distributed, or labeled by Sixarp, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN- ibuprofen suspension/ drops 
Sixarp, LLC

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Target Corporation Concentrated Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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 ibuprofen or 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

When using this product

  • give 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
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • mL = milliliter
  • measure with the dosing device provided. Do not use with any other device.
  • dispense liquid slowly into the child’s mouth, toward the inner cheek
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day
  • Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

Other information

  • store at 20-25°C (68-77°F)
  • do not freeze
  • do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions?

Call 1-888-547-7400

Principal Display Panel

see new warnings

Compare to active ingredient in Motrin® Infants' Drops Dye-Free

for ages 6 mos. to 23 mos.

dye-free

infants'

concentrated ibuprofen

oral suspension

50 mg per 1.25 mL

pain reliever/fever reducer (NSAID)

concentrated drops

non-staining

LASTS UP TO 8 HOURS

BERRY FLAVOR

AGES 6 TO 23 MONTHS

1 FL OZ (30 mL)

Use only with enclosed syringe.

infants conentrated ibuprofen image
UP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN 
ibuprofen suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59368-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN50 mg  in 1.25 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite (Opaque) Score    
ShapeSize
FlavorBERRY (mixed) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59368-003-011 in 1 CARTON07/08/2009
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 59368-003-022 in 1 CARTON08/23/2018
230 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07521707/08/2009
Labeler - Sixarp, LLC (016329513)
Establishment
NameAddressID/FEIBusiness Operations
Sixarp, LLC016329513manufacture(59368-003) , label(59368-003)

Revised: 3/2024
 

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