Ibuprofen: Package Insert and Label Information

IBUPROFEN- ibuprofen tablet, film coated
Spirit Pharmaceutical LLC

Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
  • temporarily reduces fever

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 chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning

NSAID’s except aspirin increases 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.

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

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

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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)

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • read all warnings and directions before use. Keep carton.
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium*, iron oxide red, magnesium stearate*, microcrystalline cellulose*, polyethylene glycol, polyvinyl alcohol, povidone k-30*,pregelatinized starch, sodium starch glycolate*, stearic acid*, talc, titanium dioxide.

*contains one or more of these ingredients

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENT OF
ADVIL® TABLETS*
Ibuprofen
• Ibuprofen Tablets USP, 200 mg
Pain reliever / Fever reducer (NSAID)

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IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-8100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
FERRIC OXIDE RED
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color brown Score no score
Shape ROUND Size 10mm
Flavor Imprint Code G2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-8100-5 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68210-8100-5)
2 NDC:68210-8100-3 1 BOTTLE in 1 CARTON contains a BOTTLE
2 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68210-8100-3)
3 NDC:68210-8100-2 1 BOTTLE in 1 CARTON contains a BOTTLE
3 25 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68210-8100-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079174 03/10/2020
Labeler — Spirit Pharmaceutical LLC (179621011)

Revised: 11/2022 Spirit Pharmaceutical LLC

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