IBUPROFEN PAIN RELIEVER/ FEVER REDUCER- ibuprofen suspension

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Amneal Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT

Active Ingredient                               

(in each 5 mL = 1 teaspoon)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE

Purpose

Pain reliever/ fever reducer

INDICATIONS AND USAGE

Uses

Temporarily:

• ■ Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache

• ■ Reduces fever

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 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.

OTC - DO NOT USE

Do not use:

• ■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer

• ■ right before or after heart surgery

OTC - ASK DOCTOR

Ask a doctor before use if:

• ■ 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

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the child is:

• ■ under doctor’s care for any serious condition

• ■ taking any other drug

OTC - WHEN USING

When using this product:

• ■ 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

OTC - STOP USE

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

• ■ 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

OTC - KEEP OUT OF REACH OF CHILDREN

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)

DOSAGE AND 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)

• ■ 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

Dosing Chart

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

OTHER INFORMATION

Other information

• ■ 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

INACTIVE INGREDIENTS

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

OTC - QUESTIONS

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®.

Distributed by: Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 07-2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN  PAIN RELIEVER/ FEVER REDUCER
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65162-672
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65162-672-86	1 in 1 CARTON
1		118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200457	11/12/2011

Labeler - Amneal Pharmaceuticals (123797875)

Registrant - Amneal Pharmaceuticals (123797875)

Establishment
Name	Address	ID/FEI	Business Operations
Amneal Pharmaceuticals		968119730	ANALYSIS, MANUFACTURE, LABEL, PACK