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Ibuprofen by Rugby Laboratories, Inc.

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-3603

Rugby Ibuprofen 200mg Softgels

Active Ingredient (in each capsule)

Solubilized Ibuprofen equal to 200mg Ibuprofen (NSAID)*
(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Releiver/ Fever Reducer

Uses

Temporarily relieves minor aches and pains due to:

Headache, muscle aches, minor pain of arthritis, toothache, backache, the common cold, menstrual cramps

Temporarily reduces fever.

Warnings

Allergy alert: Ibuprofen may cause a sever 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 an seek medical help right away.

Stomach bleeding warning: This prdut contains and NSAID which may cause sever stomach bleeding. The chance is higher if you:

  • are age 60 or oder
  • have had stomach ulders or bleeding problems
  • take blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks everyday while using this prdouct
  • take more or for a longer time than directed.

Do not use
  • if you 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 a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • 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 ifyou use more than directed or for longer than directed.

Stop use and ask a doctor if

You experience any of the followig signs of stomach bleeding:

  • feel faint
  • vomit blood
  • have bloody or black stoolos
  • have stomach pain that does not bet better

Pain gets worse or last more than 10 days

Fever gets worse or last more than 3 days

Stomach pain or upset gets worse or lasts

Redness or swelling is presentin 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 druing the last 3 months of pegnancy unless defintely 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 capsule every 4 to 5 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

Other information

each capsule contains

potassium 20mg

read all warnings and directions before use

store at 20-25C (68-77F)

avoid excessive heat above 40c (104F). Protect from light.

do not use if Tamper-Evident seal under bottle cap imprented with "Sealed for Your Protection" is broken or missing.

Inactive Ingredient

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

Questions or comments?

Call 1-800-645-2158, 9am - 5pm ET, Monday - Friday

Rugby Laboratories, Inc. is not affiliated with the owner of the registered trademark Advil (r). Rugby Ibuprofen is distributed by Rugby Laboratories, Inc.

Duluth, Georgia 30097
www.rugbylaboratories.com

Package Labeling

Compare to Active Ingredient in Advil NDC: 0536-3603-30

SEE NEW WARNINGS INFORMATION

Ibuprofen

Capsules, 200mg

Pain Reliever/Fever Reducer (NSAID)

80 SOFTGELS

(Liquid Filled Capsules)

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3603
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
POLYETHYLENE GLYCOL 
POTASSIUM HYDROXIDE 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
Colorblue (Light blue) Scoreno score
ShapeOVALSize18mm
FlavorImprint CodeIBU200
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3603-3080 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868203/26/2012
Labeler - Rugby Laboratories, Inc. (109178264)
Establishment
NameAddressID/FEIOperations
P and L Development of New York Corporation800014821relabel, repack
Establishment
NameAddressID/FEIOperations
Banner Pharmacaps Inc002193829manufacture

 
Rugby Laboratories, Inc.

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Medically reviewed on Mar 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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