IBUPROFEN- ibuprofen 200mg tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Mechanical Servants LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
pain reliever/fever reducer Uses: temporarily relieves minor aches and pains due to: • headache • toothache • backache • menstrual cramps • common cold • muscular aches • minor pain of arthritis • temporarily reduces fever
Authorization status:
Abbreviated New Drug Application
Authorization number:
29485-7625-6

IBUPROFEN- ibuprofen 200mg tablet, film coated

Mechanical Servants LLC

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ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

pain reliever/fever reducer

Uses:

temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps

common cold muscular aches minor pain of arthritis

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 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

presrciption 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.

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: Stomach bleeding warning applies to you you have problems or serious

side effects from taking pain relievers or fever reducers you have a history of stomach problems,

such as heartburn high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a

stroke

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: 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

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

you have symptoms of heart problems or stroke:

chst pain trouble breathing weakness in one part or side of body slurred speech leg swelling

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

Adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist. If 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.

Children under 12 years of age: ask a doctor

crosscarmellose sodium*, FD& C Blue #2*, FD& C red #40*, FD& C Yellow #6*, hypromellose*,

iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium chain

triglycerides*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*,

povidone (K-30)*, silicon dioxide, sodium starch glycolate*, starch, stearic acid*, talc*, titanium

dioxide, triacetin* *contains one or more of these ingredients

IBUPROFEN

ibuprofen 200mg tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:29 48 5-76 25

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Mechanical Servants LLC

PO VIDO NE K3 0 (UNII: U725QWY32X)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

HYPRO MELLO SE 2 2 0 8 ( 4 0 0 0 MPA.S) (UNII: 39 J8 0 LT57T)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

TRIACETIN (UNII: XHX3C3X6 73)

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

bro wn

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:29 48 5-76 25-6

3 in 1 PACKAGE

0 3/13/20 19

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 79 174

0 3/13/20 19

Labeler -

Mechanical Servants LLC (005530951)

Revised: 3/2019

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