Otc - Active Ingredient
Active Ingredient
(in each 5 mL = 1 teaspoon)
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Amneal Pharmaceuticals for the product Ibuprofen (NDC 65162-672). 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 otc - active ingredient, otc - purpose, uses, warnings, do not use:, ask a doctor before use if:, ask a doctor or pharmacist before use if the child is:, when using this product:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient
(in each 5 mL = 1 teaspoon)
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/ fever reducer
Temporarily:
■ Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
■ Reduces fever
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if your child:
■ has had stomach ulcers or bleeding problems
■ takes a blood thinning (anticoagulant) or steroid drug
■ takes other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
■ takes more or for a longer time 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.
■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgery
■ child has problems or serious side effects from taking pain relievers or fever reducers
■ stomach bleeding warning applies to your child
■ child has a history of stomach problems, such as heartburn
■ 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, or kidney disease
■ child has asthma
■ child is taking a diuretic
■ under doctor’s care for any serious condition
■ taking any other drug
■ take with food or milk if stomach upset occurs
■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
■ 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
■ the child does not get any relief within the 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)
■ 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)
■ use only enclosed measuring cup
■ if needed, repeat dose every 6-8 hours
■ do not use more than 4 times a day
■ replace original bottle cap to maintain child resistance
| Weight (lb) | Age (yr) | Dose (tsp or mL) |
| under 2 years | ask a doctor | |
| 24-35 lbs | 2-3 years | 1 tsp or 5 mL |
| 36-47 lbs | 4-5 years | 1 ½ tsp or 7.5 mL |
| 48-59 lbs | 6-8 years | 2 tsp or 10 mL |
| 60-71 lbs | 9-10 years | 2 ½ tsp or 12.5 mL |
| 72-95 lbs | 11 years | 3 tsp or 15 mL |
■ each teaspoon contains: sodium 2 mg
■ store between 20° to 25°C (68° to 77°F)
■ do not use if bottle wrap, or imprinted foil inner seal is broken or missing
■ see bottom panel for lot number and expiration date
acesulfame-potassium, anhydrous citric acid, D&C yellow # 10, FD&C red # 40, glycerin, NA bubble gum flavor FQ5511, polysorbate 80 (tween 80), purified water, sodium benzoate, sucrose, xanthan gum
Questions or Comments? Call 1-877-835-5472,
Monday through Friday 9AM - 5PM EST.
Keep the carton.
It contains important information.
See end panel for expiration date.
*This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Children’s Motrin®.
* Please review the disclaimer below.