Ibuprofen And Pseudoephedrine Hydrochloride Tablets Usp 200 Mg/30 Mg

Ibuprofen And Pseudoephedrine Hydrochloride Tablets Usp 200 Mg/30 Mg
SPL v3
SPL
SPL Set ID c01116d3-32f8-41f0-8e31-c4142265ef56
Route
ORAL
Published
Effective Date 2024-10-24
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Croscarmellose Sodium Glyceryl Mono- And Dicaprylocaprate Ferric Oxide Red Ferric Oxide Yellow Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Polyvinyl Alcohol, Unspecified Sodium Lauryl Sulfate Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 70;L Shape: oval Color: brown Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2023-03-10

Description

Active ingredients (in each caplet) Ibuprofen USP 200 mg (NSAID)*  Pseudoephedrine hydrochloride USP 30 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Nasal decongestant

Description

Active ingredients (in each caplet) Ibuprofen USP 200 mg (NSAID)*  Pseudoephedrine hydrochloride USP 30 mg *nonsteroidal anti-inflammatory drug

Uses

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

  • headache
  • fever
  • sinus pressure
  • nasal congestion
  • minor body aches and pains


Purposes

Pain reliever/fever reducer

Nasal decongestant

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.

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 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
    • do not use more than 6 caplets in any 24-hour period unless directed by a doctor
  • children under 12 years of age: do not use

Other information

  • store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40ºC (104ºF).
  • read all warnings and directions before use. Keep carton.
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.
Drug Facts

Active ingredients (in each caplet)

Ibuprofen USP 200 mg (NSAID)* 

Pseudoephedrine hydrochloride USP 30 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, glyceryl monocaprylocaprate type 1, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyvinyl alcohol-part. hydrolyzed, pregelatinized starch (maize), sodium lauryl sulfate, stearic acid, talc and titanium dioxide.



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

(Monday - Friday 8:30 AM to 5:00 PM EST)



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code: TS/DRUGS/22/2009

When Using This Product
  • take with food or milk if stomach upset occurs
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
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 at 20 weeks or later in 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.

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
Package Label Principal Display Panel 200 Mg/30 Mg (32 Tablets)

AUROHEALTH

NDC 58602-839-13


#Compare to the active

ingredients of Advil® Cold &Sinus

Non-Drowsy

COLD & SINUS RELIEF

Ibuprofen and Pseudoephedrine

Hydrochloride Tablets USP
200 mg/30 mg

Ibuprofen USP 200 mg - Pain Reliever/Fever Reducer (NSAID)

Pseudoephedrine Hydrochloride USP 30 mg - Nasal Decongestant

  • Relieves Sinus Pressure
  • Nasal Congestion and Fever

32 Coated Caplets

Oval-Shaped tablets




Structured Label Content

Uses

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

  • headache
  • fever
  • sinus pressure
  • nasal congestion
  • minor body aches and pains


Purposes

Pain reliever/fever reducer

Nasal decongestant

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.

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 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
    • do not use more than 6 caplets in any 24-hour period unless directed by a doctor
  • children under 12 years of age: do not use

Other information

  • store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40ºC (104ºF).
  • read all warnings and directions before use. Keep carton.
Do Not Use (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.
Drug Facts

Active ingredients (in each caplet)

Ibuprofen USP 200 mg (NSAID)* 

Pseudoephedrine hydrochloride USP 30 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, croscarmellose sodium, glyceryl monocaprylocaprate type 1, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyvinyl alcohol-part. hydrolyzed, pregelatinized starch (maize), sodium lauryl sulfate, stearic acid, talc and titanium dioxide.



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

(Monday - Friday 8:30 AM to 5:00 PM EST)



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code: TS/DRUGS/22/2009

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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. (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.

Ask A Doctor Or Pharmacist Before Use If You Are (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
Package Label Principal Display Panel 200 Mg/30 Mg (32 Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (32 Tablets))

AUROHEALTH

NDC 58602-839-13


#Compare to the active

ingredients of Advil® Cold &Sinus

Non-Drowsy

COLD & SINUS RELIEF

Ibuprofen and Pseudoephedrine

Hydrochloride Tablets USP
200 mg/30 mg

Ibuprofen USP 200 mg - Pain Reliever/Fever Reducer (NSAID)

Pseudoephedrine Hydrochloride USP 30 mg - Nasal Decongestant

  • Relieves Sinus Pressure
  • Nasal Congestion and Fever

32 Coated Caplets

Oval-Shaped tablets




Advanced Ingredient Data


Raw Label Data

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