Ibuprofen Pain Reliever/ Fever Reducer: Package Insert and Label Information

IBUPROFEN PAIN RELIEVER/ FEVER REDUCER- ibuprofen suspension
Amneal Pharmaceuticals

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

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IBUPROFEN PAIN RELIEVER/ FEVER REDUCER
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-672
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
GLYCERIN
POLYSORBATE 80
WATER
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
Product Characteristics
Color ORANGE Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-672-86 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (65162-672-86)
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 Operations
Amneal Pharmaceuticals 968119730 ANALYSIS, MANUFACTURE, LABEL, PACK

Revised: 02/2012 Amneal Pharmaceuticals

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