COUNTERACT IB- ibuprofen tablet, coated

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

Buy It Now

Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Melaleuca, Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
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 - headache - muscular aches - minor pain of arthritis - toothache - backache - the common cold - menstrual cramps - temporarily reduces fever Do not use - if you have ever had an allergic reaction to any other pain reliever/fever reducer - right before or after heart surgery Stop use and ask a doctor if - you experience any of the following signs of bleeding: - feel faint vomit blood have blood ro black stools have stomach pain that does not get better - feel faint - vomit blood - have blood ro 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
54473-308-50

COUNTERACT IB- ibuprofen tablet, coated

Melaleuca, Inc

----------

CounterAct IB Content of Label

Purpose

Pain reliever/fever reducer

Us es

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

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 you

you 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 aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

under a doctor's care for any serious condition

taking any other drug

taking any other drug containing an NSAID (prescription or nonprescription)

taking a blood thinning (anticoagulant) or steroid 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 bleeding:

feel faint

vomit blood

have blood ro 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

Adults and children 12 years and older:

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:

ask a doctor

Other information

Store between 20 to 25°C (68 to 77°F)

Read all warnings and directions before use

save carton for complete drug facts information and warnings

Inactive ingredients collodial silicon dioide, croscarmellose sodium, iron oxide red, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc,

titanium dioxide

Questions of comments? call 1-800-282-3000

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS

BROKEN OR MISSING

COUNTERACT IB

ibuprofen tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:54473-30 8

Melaleuca, Inc

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

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

TALC (UNII: 7SEV7J4R1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

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

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

STARCH, CO RN (UNII: O8 232NY3SJ)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

bro wn (Bro wn)

S core

no sco re

S hap e

ROUND (Ro und)

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:54473-30 8 -50

1 in 1 BOX

0 8 /15/20 19

1

50 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 9 1239

0 8 /15/20 19

Labeler -

Melaleuca, Inc (139760102)

Registrant -

Melaleuca, Inc (139760102)

Revised: 8/2019

Similar products

Search alerts related to this product

View documents history

Share this information