PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label Delivers 5 mL NDC 0121-1836-05 CHILDREN'S IBUPROFEN O RAL SUSPENSION (NSAID) 100 mg per 5 mL (teaspoon) SHAKE WELL Alcohol Free FOR INSTITUTIONAL USE ONLY Pkg. by: Pharmaceutical Associates, Inc. Greenville, SC 29605 SEE INSERT A18360502
OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each 5 mL) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug
INDICATIONS & USAGE SECTION.
Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
DOSAGE & ADMINISTRATION SECTION.
Directions this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. if needed repeat dose every 68 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Dose (mL) **or as directed by a doctor Under 24 lbs under 2 years ask a doctor 2435 lbs 23 years 5 mL 3647 lbs 45 years 7.5 mL 4859 lbs 68 years 10 mL 6071 lbs 910 years 12.5 mL 7295 lbs 11 years 15 mL
SPL UNCLASSIFIED SECTION.
Gluten Free DISTRIBUTED BY MAJOR PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 PACKAGED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharm.com R12/17
INACTIVE INGREDIENT SECTION.
Inactive ingredients anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum.
STORAGE AND HANDLING SECTION.
Other information each 5 mL contains: sodium 2 mg store at 20 to 25C (68 to 77F) do not freeze Children's Ibuprofen Oral Suspension is an orange, berry flavored suspension supplied in the following oral dosage form: NDC 0121-1836-05: 5 mL unit dose cup. Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each.
OTC - QUESTIONS SECTION.
Questions or comments? Call 1-800-845-8210. You may also report serious side effects to this phone number.
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 the child has ever had an allergic reaction to ibuprofen or 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 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 the child is 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 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 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 (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)
OTC - PURPOSE SECTION.
Purposes Pain reliever/Fever reducer