HEALTH SENSE INFANTS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension 
Dolgencorp Inc

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Dollar General Health Sense Infants' Ibuprofen Oral Suspension, Berry Flavor Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.

The chance is higher if the child:

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 the child has

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • not been drinking fluids
  • lost a lot of fluid due to vomiting or diarrhea
  • high blood pressure
  • heart or kidney disease
  • taken a diuretic

Ask a doctor or pharmacist before use if the child is

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product

  • give with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

  • the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
  • stomach pain or upset gets worse or lasts
  • 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.

Directions

Dosing Chart

Weight (lb)Age (mos)Dose (mL)
under 6 mosask a doctor
12-17 lbs6-11 mos1.25 mL
18-23 lbs12-23 mos1.875 mL

Other information

Inactive ingredients

artificial flavor, butylparaben, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

Questions or comments?

1-888-309-9030

Principal Display Panel

 Compare to active ingredient of Motrin® Infants' Drops

Concentrated

For Ages 6 mos.-23 mos.

Infants' Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Alcohol Free

Use Only With Enclosed Syringe

Berry Flavor

Product Carton

Product Carton

Product Label

Product Label

HEALTH SENSE INFANTS IBUPROFEN  ORAL SUSPENSION
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN50 mg  in 1.25 mL
Product Characteristics
ColorPINK (light) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-057-051 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07521706/08/2009
Labeler - Dolgencorp Inc (068331990)

Revised: 5/2009
Document Id: 78f524ac-3498-480d-8979-653c8a5c5674
Set id: 73e309a5-a8c2-4496-aeff-7251b640a45d
Version: 1
Effective Time: 20090522
 
Dolgencorp Inc