Drugplain

profen ib infants 50 mg/1.25mL

ibuprofen · SUSPENSION · Publix Super Markets Inc

No Recall History
Plain English

profen ib infants is a suspension containing ibuprofen at 50 mg/1.25mL, taken oral. Manufactured by Publix Super Markets Inc.

Key Facts

Brand Name
profen ib infants
Generic Name
ibuprofen
NDC Code (Product)
56062-057
Manufacturer
Publix Super Markets Inc
Strength
50 mg/1.25mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
ANDA075217
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
06/29/2001

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

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

Frequently Asked Questions

What is profen ib infants used for?

profen ib infants contains ibuprofen. It is a suspension taken oral. Consult your doctor for specific uses.

Is profen ib infants a controlled substance?

profen ib infants is not classified as a controlled substance by the DEA.

What is the generic name for profen ib infants?

The generic name for profen ib infants is ibuprofen. There are 12 other brand versions of ibuprofen.

What is the NDC code for profen ib infants 50 mg/1.25mL?

The NDC (National Drug Code) for profen ib infants 50 mg/1.25mL is 56062-057, listed by Publix Super Markets Inc.