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Ibuprofen Liqui-gels

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg
Labeler: Allegiant Health
NDC Code: 69168-363

Drug Facts

Active ingredient

Solubilized ibuprofen equal to 200mg ibuprofen (NSAID)**
(present as the free acid and potassium salt)
**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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

■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburn you
have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you have asthma you are taking a diuretic

Ask a doctor or pharmacist before use if

you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition taking any other drug

When using this product

take with food or milk if stomach upset occurs
long term continuous use may increase the risk of heart attack or stroke

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 (1-800-222-1222).

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 older: take 1 softgel every 4 to 6 hours while symptoms persist ■ if pain or fever does not respond to 1 softgel, 2 softgels may be used ■ do not exceed 6 softgels in 24 hours unless directed by a doctor
Children under 12 years: ask a doctor

Inactive Ingredients

Ammonium hydroxide, FD&C green #3, gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol sorbitan, Sorbitan monooleate

Package/Label Principal Display Panel
IBUPROFEN  LIQUI-GELS
ibuprofen 200 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-363
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ShapeCAPSULESize15mm
FlavorImprint Code133
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-363-0710 CAPSULE, LIQUID FILLED in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920512/22/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-363), MANUFACTURE(69168-363), LABEL(69168-363), PACK(69168-363), RELABEL(69168-363), REPACK(69168-363)

Revised: 12/2014
 
Allegiant Health

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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