Advil Liqui-gels

Advil Liqui-gels
SPL v12
SPL
SPL Set ID c459ea1e-dabf-bba6-e053-2995a90af40f
Route
ORAL
Published
Effective Date 2023-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Gelatin Fd&c Green No. 3 Potassium Hydroxide Water Lecithin, Soybean Medium-chain Triglycerides Sorbitan Polyethylene Glycol, Unspecified Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: Advil Shape: oval Color: green Size: 20 mm Score: 1
Marketing Status
NDA Active Since 2003-02-28 Until 2025-10-13

Description

Drug Facts

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

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.

Section 55106-9

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID) 1 (present as the free acid and potassium salt)



1 - nonsteroidal anti-inflammatory drug

Directions

do not take more than directed

the smallest effective dose should be used


adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist

if pain or fever does not respond to 1 capsule, 2 capsules may be used

do not exceed 6 capsules in 24 hours, unless directed by a doctor

children under 12 years: ask a doctor

Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
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.

Other Information

each capsule contains: potassium 20 mg

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 Ingredients

FD&C green no. 3, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Questions Or Comments?

call toll free 1-800-88-ADVIL

When Using This Product
  • take with food or milk if stomach upset occurs
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
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, 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
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
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.

Advil Liqui Gels Cvp 4 Count Carton

Advil ®



LIQUI•GELS®

Solubilized Ibuprofen Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

4

Liquid Filled

Capsules

CVP

HEALTH

Ask A Doctor Or Pharmacist Before Use If You Are
  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug
Principal Display Panel 200 Mg Capsule Pouch Carton

Advil



LIQUI•GELS®

Solubilized Ibuprofen Capsules, 200 mg



Pain Reliever/Fever Reducer (NSAID)

2 PACKETS OF 2 LIQUID FILLED CAPSULES EACH


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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.

Section 55106-9 (55106-9)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID) 1 (present as the free acid and potassium salt)



1 - nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Directions

do not take more than directed

the smallest effective dose should be used


adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist

if pain or fever does not respond to 1 capsule, 2 capsules may be used

do not exceed 6 capsules in 24 hours, unless directed by a doctor

children under 12 years: ask a doctor

Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Allergy Alert (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.

Other Information

each capsule contains: potassium 20 mg

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 Ingredients (INACTIVE INGREDIENTS)

FD&C green no. 3, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call toll free 1-800-88-ADVIL

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (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
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, 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
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
Heart Attack and Stroke Warning (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.

Advil Liqui Gels Cvp 4 Count Carton (ADVIL LIQUI-GELS CVP 4 Count Carton)

Advil ®



LIQUI•GELS®

Solubilized Ibuprofen Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

4

Liquid Filled

Capsules

CVP

HEALTH

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 aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug
Principal Display Panel 200 Mg Capsule Pouch Carton (PRINCIPAL DISPLAY PANEL - 200 MG CAPSULE POUCH CARTON)

Advil



LIQUI•GELS®

Solubilized Ibuprofen Capsules, 200 mg



Pain Reliever/Fever Reducer (NSAID)

2 PACKETS OF 2 LIQUID FILLED CAPSULES EACH


Advanced Ingredient Data


Raw Label Data

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