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IBUPROFEN by FRED'S INC.

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg
Labeler: FRED'S INC.
NDC Code: 55315-940

frd 940

Active ingredient (in each capsule)

Solubilized Ibuprofen equal to
ibuprofen 200 mg (NSAID)*

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

Purpose

PAIN RELIEVER/ FEVER REDUCER

Uses

temporarily relieves minor aches and pain due to :

  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis

temporarily reduces fever

Warnings

Allergy alerts: 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 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
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

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
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
  • 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
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • 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

Other information
  • each capsule contains: potassium 20g
  • read all Warnings and Directions before use
  • store at controlled room temperature
  • avoid excessive heat 40C (104F) or above

Inactive ingredients

ammonium hydroxide, FD&C green #3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitan monooleate, sorbitol sorbitan

Package label

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-940
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SORBITAN 
AMMONIA 
FD&C GREEN NO. 3 
GELATIN 
FERROSOFERRIC OXIDE 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
POTASSIUM HYDROXIDE 
WATER 
SHELLAC 
SORBITAN MONOOLEATE 
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code133
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-940-041 BOTTLE in 1 CARTON
140 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:55315-940-081 BOTTLE in 1 CARTON
280 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920501/01/2017
Labeler - FRED'S INC. (005866116)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
NameAddressID/FEIOperations
Geri-Care Pharmaceutical Corp611196254repack(55315-940)

Revised: 12/2017
 
FRED'S INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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