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  5. Label Information: Advil Multi-symptom Cold And Flu

FDA Label for Advil Multi-symptom Cold And Flu

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSES
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. ALLERGY ALERT: IBUPROFEN MAY CAUSE A SEVERE ALLERGIC REACTION, ESPECIALLY IN PEOPLE ALLERGIC TO ASPIRIN. SYMPTOMS MAY INCLUDE:
    6. STOMACH BLEEDING WARNING: THIS PRODUCT CONTAINS AN NSAID, WHICH MAY CAUSE SEVERE STOMACH BLEEDING. THE CHANCE IS HIGHER IF YOU:
    7. DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF
    9. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    10. WHEN USING THIS PRODUCT
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DOSAGE & ADMINISTRATION
    15. STORAGE AND HANDLING
    16. INACTIVE INGREDIENT
    17. OTC - QUESTIONS
    18. ADDITIONAL INFORMATION
    19. PRINCIPAL DISPLAY PANEL

Advil Multi-symptom Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Tablet)



Chlorpheniramine maleate 4 mg

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug


Purposes



Antihistamine

Pain reliever/Fever reducer

Nasal decongestant


Indications & Usage



Uses

  • •temporarily relieves these symptoms associated with the common cold or flu:
    • •headache
    • •fever
    • •minor body aches and pains
    • •nasal congestion
    • •runny nose
    • •sinus pressure
    • •sneezing
    • •reduces swelling of the nasal passages
    • •temporarily restores freer breathing through the nose

Warnings



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

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



  • •you have a breathing problem such as emphysema or chronic bronchitis
  • •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, glaucoma, 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 sedatives or tranquilizers
  • •taking any other product that contains phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine
  • •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
  • •avoid alcoholic drinks
  • •be careful when driving a motor vehicle or operating machinery
  • •drowsiness may occur
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •may cause excitability especially in children

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
      • •pain gets worse or lasts more than 7 days
      • •fever gets worse or lasts more than 3 days
      • •nasal congestion lasts for more than 7 days
      • •redness or swelling is present in the painful area
      • •you get nervous, dizzy, or sleepless
      • •symptoms continue or get worse
      • •any new symptoms appear

Otc - Pregnancy 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.


Otc - 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 right away.


Dosage & Administration



Directions

  • •do not take more than directed
  • •adults and children 12 years of age and over:
    • •take 1 tablet every 4 hours while symptoms persist
    • •do not take more than 6 tablets in any 24-hour period, unless directed by a doctor
    • •children under 12 years of age: do not use

Storage And Handling



Other information

  • •read all warnings and directions before use. Keep carton.
  • •store at 20-25°C (68-77°F)
  • •avoid excessive heat above 40°C (104°F)

Inactive Ingredient



Inactive ingredients

acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl dibehenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum


Otc - Questions



Questions or comments? Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL


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.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information,

visit www.advil.com

Trademarks owned or licensed by GSK ©2021 GSK or licensor


Principal Display Panel



Advil

MULTI-SYMPTOM
COLD & FLU

Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant
Chlorpheniramine Maleate 4 mg Antihistamine

* Please review the disclaimer below.