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Childrens Ibuprofen by Fred's Inc.

Medically reviewed on December 28, 2017

Dosage form: suspension
Ingredients: IBUPROFEN 100mg in 5mL
Labeler: Fred's Inc.
NDC Code: 55315-552

Ibuprofen Oral Suspension, USP

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Ibuprofen, USP 100 mg (NSAID)**
**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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
  • shock
  • asthma (wheezing)
  • rash
  • skin reddening
  • blisters
  • facial swelling

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

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 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, or kidney disease
  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • the child does not get any relief within the 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.  If possible, use weight to dose; otherwise use age.
  • use only enclosed measuring cup
  • if â€‹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)

  

Age (yr)

  

Dose (tsp or mL)

  

under 2 years

  

ask a doctor

  

24-35 lbs

  

2-3 years

  

1 tsp or 5 mL

  

36-47 lbs

  

4-5 years

  

1 ½ tsp or 7.5 mL

  

48-59 lbs

  

6-8 years

  

2 tsp or 10 mL

  

60-71 lbs

  

9-10 years

  

2 ½ tsp or 12.5 mL

  

72-95 lbs

  

11 years

  

3 tsp or 15 mL

Other information
  • each teaspoon contains: sodium 2 mg 
  • do not use if printed neckband is broken or missing
  • store between 20 - 25°C (68 - 77°F)
  • see bottom panel for lot number and expiration date

Inactive ingredients

Original  Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum 

Grape flavor: citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, hypromellose, polysorbate -80, purified water, sodium benzoate, sucrose, xanthan gum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL – ORIGINAL BERRY FLAVOR

fred’s KIDS®

For ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP (NSAID)
100 mg per 5 mL (teaspoon) 

Pain Reliever
Fever Reducer
Lasts Up To 8 Hours 

Shake Well Before Using
Original Berry Flavor
Alcohol Free

4 fl oz (118 mL)

Compare to the active ingredient in:
Children’s Motrin®

PRINCIPAL DISPLAY PANEL – GRAPE FLAVOR

fred’s KIDS® 

For ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP (NSAID)
100 mg per 5 mL (teaspoon) 

Pain Reliever
Fever Reducer
Lasts Up to 8 Hours 

Shake Well Before Using

Grape Flavor
Alcohol Free 

4 fl oz (118 mL)
Compare to the active ingredient in:
Children’s Motrin®

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-552
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSE 2910 (4000 MPA.S) 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-552-941 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491606/01/2006
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-262
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSE 2910 (4000 MPA.S) 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-262-941 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491603/24/2008
Labeler - Fred's Inc. (005866116)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

 
Fred's Inc.

← See all Childrens Ibuprofen brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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