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IBUPROFEN by TIME CAP LABORATORIES, INC

Medically reviewed on November 15, 2017

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg
Labeler: TIME CAP LABORATORIES, INC
NDC Code: 49483-610

Solubilized Ibuprofen equal to
200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

AMMONIA, FD&C GREEN #3, GELATIN, FERROSOFERRIC OXIDE, MEDIUM CHAIN TRIGLYCERIDES, POLYETHYLENE GLYCOL, PROPYLENE GLYCOL, POTASSIUM HYDROXIDE, WATER, SHELLAC, SORBITAN MONOOLEATE, SORBITAN

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

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

PAIN RELIEVER/ FEVER REDUCER

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

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.

IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-610
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 
SORBITAN 
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code133
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-610-4440 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920512/23/2015
Labeler - TIME CAP LABORATORIES, INC (037052099)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIOperations
MARKSANS PHARMA LIMITED925822975manufacture(49483-610)

 
TIME CAP LABORATORIES, INC

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Further information

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

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