IBUPROFEN AND PSEUDOEPHEDRINE HCL capsule, liquid filled

Ibuprofen and Pseudoephedrine HCl by

Drug Labeling and Warnings

Ibuprofen and Pseudoephedrine HCl by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
  • 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)

INGREDIENTS AND APPEARANCE

IBUPROFEN AND PSEUDOEPHEDRINE HCL 
ibuprofen and pseudoephedrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-609
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE (Light Orange to Light Yellow with a Slight Orange hue)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	IBP200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-609-58	4 in 1 CARTON	12/01/2017
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209235	12/01/2017

Labeler - Amerisource Bergen (007914906)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(46122-609) , MANUFACTURE(46122-609)