Active Ingredient (In Each 5 Ml)
Ibuprofen, USP 100 mg (NSAID)**
**Nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Pain And Fever (NDC 51316-938). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if your child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen, USP 100 mg (NSAID)**
**Nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily
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.
take with food or milk if stomach upset occurs
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosing Chart
| Weight (lb) | Age (yr) | Dose (mL)* |
| under 24 | under 2 | ask a doctor |
| 24-35 | 2-3 | 5 mL |
| 36-47 | 4-5 | 7.5 ml |
| 48-59 | 6-8 | 10 mL |
| 60-71 | 9-10 | 12.5 mL |
| 72-95 | 11 | 15 mL |
*or as directed by a doctor
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
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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
* Please review the disclaimer below.