IBUPROFEN AND PSEUDOEPHEDRINE HCL capsule, liquid filled

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

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
Available from:
Amerisource Bergen
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Nasal decongestant temporarily relieves these symptoms associated with the common cold or flu: - headache - sinus pressure - nasal congestion - minor body aches and pains - fever - in children under 12 years of age - if you have ever had an allergic reaction to any other pain reliever/fever reducer - right before or after heart surgery - if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. - 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 - you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinati
Authorization status:
Abbreviated New Drug Application
Authorization number:
46122-609-58

IBUPROFEN AND PSEUDOEPHEDRINE HCL - ibuprofen and pseudoephedrine hcl capsule,

liquid filled

Amerisource Bergen

----------

Ibuprofen and Pseudoephedrine HCl Capsules 200 mg/30 mg

Drug Facts

Active ingredients (in each liquid-filled capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*

(present as the free acid and potassium salt)

Pseudoephedrine Hydrochloride USP 30 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Nasal decongestant

Uses

temporarily relieves these symptoms associated with the common cold or flu:

headache

sinus pressure

nasal congestion

minor body aches and pains

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 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.

Do not use

in children under 12 years of age

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

right before or after heart surgery

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after

stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a

doctor or pharmacist before taking this product.

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

you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid

disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke

you are taking a diuretic

Ask a doctor or pharmacist before use if you are

under a doctor’s care for any serious condition

taking any other product that contains pseudoephedrine or any other nasal decongestant

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

trouble breathing

weakness in one part or side of body

weakness in one part or side of body

slurred speech

leg swelling

fever gets worse or lasts more than 3 days

nasal congestion lasts for more than 7 days

symptoms continue or get worse

redness or swelling is present in the painful area

you get nervous, dizzy, or sleepless

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 of age and over:

take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1

capsule, 2 capsules may be used.

do not use more than 6 capsules in any 24-hour period unless directed by a doctor

children under 12 years of age: do not use

Other information

each capsule contains: potassium 20 mg

store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F).

read all warnings and directions before use. Keep carton.

Inactive ingredients

Black iron oxide, D&C yellow no. 10, gelatin, hypromellose, neelicert FD&C red no. 40, polyethylene

glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution.

Questions or comments? call 1-855-274-4122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code:TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (20 Liquid-Filled Capsules)

GOOD

NEIGHBOR

PHARMACY

*Compare to the Advil

Cold & Sinus

active ingredients

NDC 46122-609-58

Non-Drowsy

COLD & SINUS RELIEF

Ibuprofen and Pseudoephedrine HCl Capsules

200 mg/30 mg

Pain Reliever/Fever Reducer (NSAID)/Nasal Decongestant

Relieves Sinus Pressure, Nasal Congestion and Fever

40 Liquid-Filled Capsules (4 X 10 capsules per blister card)

®

IBUPROFEN AND PSEUDOEPHEDRINE HCL

ibuprofen and pseudoephedrine hcl capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 122-6 0 9

Route of Administration

ORAL

Amerisource Bergen

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

PSEUDO EPHEDRINE HYDRO CHLO RIDE (UNII: 6 V9 V2RYJ8 N) (PSEUDOEPHEDRINE

- UNII:7CUC9 DDI9 F)

PSEUDOEPHEDRINE

HYDROCHLORIDE

30 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

PO LYETHYLENE GLYCO L 6 0 0 (UNII: NL4J9 F21N9 )

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics

Color

ORANGE (Light Orange to Light Yello w with a Slight Orange hue)

S core

no sco re

S hap e

OVAL

S iz e

15mm

Flavor

Imprint Code

IBP20 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:46 122-6 0 9 -58

4 in 1 CARTON

12/0 1/20 17

1

10 in 1 BLISTER PACK; 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

ANDA20 9 235

12/0 1/20 17

Labeler -

Amerisource Bergen (007914906)

Registrant -

Aurohealth LLC (078728447)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Auro bindo Pharma Limited

6 50 38 19 0 3

ANALYSIS(46 122-6 0 9 ) , MANUFACTURE(46 122-6 0 9 )

Revised: 10/2019

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