PAIN AND FEVER- ibuprofen suspension 
CVS PHARMACY, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each 5 mL)

Ibuprofen, USP 100 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 an NSAID, which may cause stomach bleeding.

The chance is higher if your child:

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 a doctor.

Do not use

  • if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after hear surgery

Ask a doctor before use if

  • stomach bleeding warning applies to your child
  • child has 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 your 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

Stop use and ask a doctor if

  • child experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomit 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 (24hours) 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 appera

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Dosing Chart

Weight (lb)Age (yr)Dose (mL)*
 under 24under 2ask a doctor
 24-352-35 mL
 36-474-5 7.5 ml
 48-596-810 mL
 60-719-1012.5 mL
 72-951115 mL

*or as directed by a doctor

Other information


Inactive ingredients

acesulfame potassium, artifical grape flavor, citric acid anhydrous, FD&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purfied water, sodium benzoate, sucrose, xanthan gum

Questions or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to the active ingredients in Children's Motrin®†

For ages 2 to 11

Children's

Ibuprofen

Oral Suspension

100 mg per 5 mL

Pain reliever;

Fever reducer NSAID

No added alcohol

LAST UP TO 8 HOURS

Grape Flavor

Dosage Cup Included

FL OZ (mL)

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Motrin®.

TAMPER EVIDENT: DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Product Label

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

CVS HEALTH Ibuprofen 100 mg

PAIN AND FEVER 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-938
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-938-041 in 1 BOX02/15/2023
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/15/2023
Labeler - CVS PHARMACY, INC (062312574)

Revised: 3/2023
Document Id: b420b3bc-92db-4909-b718-9abd53285c39
Set id: 454a1ba4-5609-4616-a1fd-0c224d1a9442
Version: 1
Effective Time: 20230315
 
CVS PHARMACY, INC