Drug Facts

Drug Facts
SPL v13
SPL
SPL Set ID 0da9ed22-bfb4-d61b-110b-0c7760332a98
Route
ORAL
Published
Effective Date 2022-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Red No. 40 Gelatin, Unspecified Medium-chain Triglycerides Polyethylene Glycol, Unspecified Potassium Hydroxide Water Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: Advil;C;S Shape: oval Color: orange Size: 15 mm Score: 1
Marketing Status
NDA Active Since 2002-05-30

Description

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) Pseudoephedrine HCl 30 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Nasal decongestant

Description

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) Pseudoephedrine HCl 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

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
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.
Other Information
  • each capsule contains: potassium 20 mg
  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.
Inactive Ingredients

D&C yellow no. 10, FD&C red no. 40, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Additional Information

READ AND KEEP CARTON FOR COMPLETE

WARNINGS AND INFORMATION

Product inside sealed in plastic blister with foil backing.

Do Not Use if plastic blister or foil barrier is broken.

For most recent product information,

visit www.advil.com

Questions Or Comments?

Call weekdays from 9 AM to 5 PM ESTtoll free at 1-800-88-ADVIL

Principal Display Panel

Advil

COLD & SINUS Non-Drowsy

Ibuprofen 200 mg ‣ Pain Reliever/Fever Reducer (NSAID)

Pseudoephedrine HCl 30 mg ‣ Nasal Decongestant

Relieves Sinus Pressure,

Nasal Congestion and Fever

LIQUI-GELS ®

Advil

C & S

32 LIQUID-FILLED CAPSULES

000065783 Carton

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.

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
Active Ingredients (in Each Liquid Filled Capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug

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

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

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
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.
Other Information (Other information)
  • each capsule contains: potassium 20 mg
  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.
Inactive Ingredients (Inactive ingredients)

D&C yellow no. 10, FD&C red no. 40, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Additional Information

READ AND KEEP CARTON FOR COMPLETE

WARNINGS AND INFORMATION

Product inside sealed in plastic blister with foil backing.

Do Not Use if plastic blister or foil barrier is broken.

For most recent product information,

visit www.advil.com

Questions Or Comments? (Questions or comments?)

Call weekdays from 9 AM to 5 PM ESTtoll free at 1-800-88-ADVIL

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Advil

COLD & SINUS Non-Drowsy

Ibuprofen 200 mg ‣ Pain Reliever/Fever Reducer (NSAID)

Pseudoephedrine HCl 30 mg ‣ Nasal Decongestant

Relieves Sinus Pressure,

Nasal Congestion and Fever

LIQUI-GELS ®

Advil

C & S

32 LIQUID-FILLED CAPSULES

000065783 Carton

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.

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
Active Ingredients (in Each Liquid Filled Capsule) (Active ingredients (in each liquid-filled capsule))

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug

Allergy Alert: Ibuprofen May Cause A Severe Allergic Reaction, Especially in People Allergic to Aspirin. Symptoms May Include: (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: (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

Advanced Ingredient Data


Raw Label Data

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