IBUPROFEN 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:
Rugby Laboratories
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: backache muscular aches toothache menstrual cramps headache the common cold minor pain of arthritis - backache - muscular aches - toothache - menstrual cramps - headache - the common cold - minor pain of arthritis - temporarily reduces fever
Authorization status:
Abbreviated New Drug Application
Authorization number:
0536-1089-01

IBUPROFEN- ibuprofen tablet, film coated

Rugby Laboratories

----------

Rugby 44-292-delisted

Active ingredient (in each brown caplet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

backache

muscular aches

toothache

menstrual cramps

headache

the common cold

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:

shock

facial swelling

blisters

rash

hives

skin reddening

asthma (wheezing)

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:

take more or for a longer time than directed

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen,

or others]

are age 60 or older

have had stomach ulcers or bleeding problems

have 3 or more alcoholic drinks every day while using this product

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

right before or after heart surgery

if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you are taking a diuretic

you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

you have problems or serious side effects from taking pain relievers or fever reducers

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

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

you have symptoms of heart problems or stroke

chest pain

slurred speech

leg swelling

trouble breathing

weakness in one part or side of body

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 (1-800-222-1222) right away.

Directions

do not take more than directed

the smallest effective dose should be used

adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist

if pain or fever does not respond to 1 caplet, 2 caplets may be used

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

children under 12 years: ask a doctor

Other information

store between 20º-25ºC (68º-77ºF)

avoid excessive heat 40ºC (104ºF)

see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium

stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch

glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-645-2158

Principal Display Panel

Rugby

NDC 0536-1089-01

Compare to the active ingredient in Advil

Caplets

Ibuprofen

Tablets USP, 200 mg

Pain Reliever/Fever Reducer

(NSAID)

100 COATED CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by Wyeth

Consumer Healthcare, owner of the registered trademark

Advil® Caplets.

50844 REV1116A29212

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA www.rugbylaboratories.com

R-17 Re-order No. 301937 Rev. 09/17

®

Rug by 4 4 -292

IBUPROFEN

ibuprofen tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 536 -10 8 9

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

STARCH, CO RN (UNII: O8 232NY3SJ)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

BROWN

S core

no sco re

S hap e

OVAL

S iz e

14mm

Flavor

Imprint Code

44;29 2

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 536 -10 8 9 -0 1

1 in 1 CARTON

0 5/24/19 8 8

11/0 6 /20 22

1

10 0 in 1 BOTTLE; 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 750 10

0 5/24/19 8 8

11/0 6 /20 22

Labeler -

Rugby Laboratories (079246066)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(0 536 -10 8 9 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Rugby Laboratories

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(0 536 -10 8 9 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(0 536 -10 8 9 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(0 536 -10 8 9 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(0 536 -10 8 9 )

Revised: 3/2020

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