Quality Choice Ibuprofen 200: Package Insert and Label Information

QUALITY CHOICE IBUPROFEN 200 — ibuprofen tablet
Chain Drug Marketing Association

Active ingredient

Ibuprofen 200 mg (NSAID)1

—————————————————-

1nonsteroidal anti-inflammatory drug

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 an 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


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

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of 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
  • 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.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • 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 at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive Ingredient s

colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl celluose, hypromellose, microcrystalline

celluose, pregelatinized starch, stearic acid, titanium dioxide

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QUALITY CHOICE IBUPROFEN 200
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-977
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
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (TYPE E)
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color brown Score no score
Shape ROUND Size 10mm
Flavor Imprint Code IBU200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63868-977-08 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 8 TABLET in 1 BLISTER PACK This package is contained within the CARTON (63868-977-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079129 07/23/2014
Labeler — Chain Drug Marketing Association (011920774)
Registrant — Reese Pharmaceutical Co (004172052)
Establishment
Name Address ID/FEI Operations
Reese Pharmaceutical Co 004172052 relabel (63868-977), repack (63868-977)

Revised: 06/2015 Chain Drug Marketing Association

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