Available Formats

• Active ingredient (in each capsule)

  Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

  (present as the free acid and potassium salt)
  *nonsteroidal anti-inflammatory drug

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• Purpose

  Pain reliever/fever reducer

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• Uses

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

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• 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

  • 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
  • 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
    • have bloody or black stools
    • vomit blood
    • 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.

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• Directions

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

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• Other information

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton 
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.

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• Inactive ingredients

  FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

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• Questions or comments?

  Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

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• Principal Display Panel

  Compare to Advil® Liquid-Gels® active ingredients† 

  Ibuprofen Capsules, 200 mg

  Pain Reliever

  Fever Reducer (NSAID)

  Softgels**

  (**LIQUID FILLED CAPSULES)

  †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Liqui-Gels®.

  DISTRIBUTED BY

  BETTER LIVING BRANDS LLC

  P.O. BOX 99, PLEASANTON, CA 94566-0009

  DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

  KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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• Product Label

  

  Signature Care Ibuprofen 200mg softgels

   

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• INGREDIENTS AND APPEARANCE

  IBUPROFEN  ibuprofen capsule, liquid filled

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-197 Route of Administration ORAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg

  Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD)   GELATIN (UNII: 2G86QN327L)   POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)   POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)   WATER (UNII: 059QF0KO0R)   SORBITOL (UNII: 506T60A25R)   SORBITAN (UNII: 6O92ICV9RU)

  Product Characteristics Color BLUE Score no score Shape CAPSULE Size 19mm Flavor Imprint Code IB200 Contains

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-197-80 1 in 1 BOX 1 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:21130-197-40 1 in 1 BOX 2 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:21130-197-20 1 in 1 BOX 3 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:21130-197-03 300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:21130-197-18 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078682 07/06/2010

  Labeler - Safeway, Inc. (009137209)

  Registrant - P & L Development, LLC (800014821)

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