Ibuprofen by Preferred Pharmaceuticals Inc. GC 941

Ibuprofen by

Drug Labeling and Warnings

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

Drug Details [pdf]

IBUPROFEN- ibuprofen tablet, film coated 
Preferred Pharmaceuticals Inc.

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GC 941

Active ingredient (in each brown tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal 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:

  • shock
  • hives
  • facial swelling
  • asthma (wheezing)
  • 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
    Heart attack and stroke warning: NSAIDs, except aspirin, increase
    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 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

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
  • you have symptoms of heart problems or stroke:
    - chest pain - trouble breathing - leg swelling
    - slurred speech - weakness in one part or side of body
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur

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 (1-800-222-1222) right away.

Directions

  • do not use 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 take more than 6 tablets in 24 hours unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at controlled room temperature
  • avoid excessive heat 40°C (104°F)

Inactive ingredients

carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.

Questions or comments?

Call 1-800-540-3765

Package label

GERICARE

Repackaged By: Preferred Pharmaceuticals Inc.

NDC: 68788-7156

IBUPROFEN

pain reliever/fever reducer (NSAID)

COMPARE TO THE ACTIVE INGREDIENT IN ADVIL*



200 mg each

Tamper Evident:

Do not use if imprinted seal under cap is missing or broken.

Ibuprofen Tablets, USP 200mg
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-7156(NDC: 57896-941)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44291
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-7156-220 in 1 BOTTLE; Type 0: Not a Combination Product06/12/202011/14/2022
2NDC: 68788-7156-330 in 1 BOTTLE; Type 0: Not a Combination Product06/12/202011/14/2022
3NDC: 68788-7156-440 in 1 BOTTLE; Type 0: Not a Combination Product06/12/202011/14/2022
4NDC: 68788-7156-550 in 1 BOTTLE; Type 0: Not a Combination Product06/12/202011/14/2022
5NDC: 68788-7156-660 in 1 BOTTLE; Type 0: Not a Combination Product06/12/202011/14/2022
6NDC: 68788-7156-990 in 1 BOTTLE; Type 0: Not a Combination Product06/12/202011/14/2022
7NDC: 68788-7156-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/12/202011/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501006/12/202011/14/2022
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-7156)

Revised: 11/2022