IBUPROFEN by REMEDYREPACK INC.

Drug Details [pdf]

IBUPROFEN- ibuprofen tablet, film coated
REMEDYREPACK INC.

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Ibuprofen 200 mg (NSAID)* * nonstreoidal anti-inflammatory drug

Pain reliever / fever reducer

In case of overdose, get medical help or contact a PoisonControlCenter right away. (1-800-222-1222)

colloidal silicon dioxide, croscamellose sodiium, iron oxide red, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium

do not take more than directed

the smallest effective dose should be used

do not take longer than 10 days, unless directed by a docter
(see Wanings)

adults and children 12 years and olderChildren under 12 years

take 1 tablet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 tablet, 2 tablets may be used

do not exceed 6 tablets in 24 hours, unless directed by a doctor.

ask a doctor

temporarily relieves minor aches and pain due to :backache,headache,menstrual cramps, minor pain of arthritismuscular aches, the common cold, toothache, temporarily reduces fever

Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include: asthma (wheezing),blisters,facial swelling,hives,rash,shock,skin reddening

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 stomach bleeding. The chance is higher if you:are age 60 or older; have bad stomach ulcers or bleeding problems;take a blood thinning (anticoagulant) or steroid drug; take other drug containing prescription NSAID (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.

PRINCIPAL DISPLAY PANEL

DRUG: IBUPROFEN

GENERIC: IBUPROFEN

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-948-02

COLOR: brown

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 10 mm

IMPRINT: 114

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

IBUPROFEN 200mg in 1

INACTIVE INGREDIENT(S):

CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOLS
STARCH, PREGELATINIZED CORN
TALC
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
SILICON DIOXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE

Remedy_Label

IBUPROFEN
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61786-948(NDC: 49483-601)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	114
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 61786-948-02	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/19/2016	04/09/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091239	10/19/2016	04/09/2018

Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2020

Document Id: 7bd65b5e-efaf-f1f1-e053-2991aa0ac612

Set id: 05b49221-10b8-4fd5-93b3-d75d7d0d2983

Version: 2

Effective Time: 20200128