Advil ®

Advil ®
SPL v12
SPL
SPL Set ID b876bb40-a38b-445a-bc8a-466b3bfe166d
Route
ORAL
Published
Effective Date 2022-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg) Diphenhydramine (38 mg)
Inactive Ingredients
Calcium Stearate Carnauba Wax Silicon Dioxide Starch, Corn Croscarmellose Sodium Fd&c Blue No. 2 Aluminum Oxide Glyceryl Dibehenate Hypromellose, Unspecified Lactose Monohydrate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Advil;PM Shape: oval Color: blue Size: 15 mm Score: 1
Marketing Status
NDA Active Since 2022-05-06 Until 2018-11-25

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep
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 55105-1
Active ingredients (in each caplet) Purposes
Diphenhydramine citrate 38 mg Nighttime sleep-aid
Ibuprofen 200 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever
Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night's sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain
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
  • 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)
Advil Pm 4ct, Cvp ®

Advil PM

Ibuprofen, 200 mg/

Diphenhydramine Citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

4

Coated Caplets*

*Capsule-Shaped Tablets

[CVP® HEALTH logo]

Inactive Ingredients

calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

When Using This Product
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • 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
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland
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
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • 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 Pm, 6ct, Lil' Drug Store ®

Advil ® PM

Ibuprofen, 200 mg/

Diphenhydramine citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

6

Coated Caplets*

*Capsule-Shaped Tablets

[ Lil' Drug Store ® logo]

Advil Pm, 4ct Travel Basix Pdp/package

Advil PM

Ibuprofen, 200 mg/

Diphenhydramine Citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

4

Coated Caplets*

*Capsule-Shaped Tablets

[TRAVEL BASIX logo]

Advilpm 30pc Dispens It Box, Lil' Drug Store ®

AdvilPM

Ibuprofen, 200 mg/

Diphenhydramine citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

For relief of occasional

sleeplessness when

associated with minor aches and pains

Helps you fall asleep

and stay asleep

See full Drug Facts information

on the back of this dispenser

30 PACKETS OF 2 COATED CAPLETS EACH*

*Capsule-Shaped Tablets

[Lil' Drug Store® logo]

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers, or any other sleep-aid
  • under a doctor's care for any continuing medical illness
  • taking any other antihistamines
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

Structured Label Content

Uses
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep
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 55105-1 (55105-1)
Active ingredients (in each caplet) Purposes
Diphenhydramine citrate 38 mg Nighttime sleep-aid
Ibuprofen 200 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever
Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night's sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain
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 (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)
Advil Pm 4ct, Cvp ® (Advil PM 4ct, CVP ®)

Advil PM

Ibuprofen, 200 mg/

Diphenhydramine Citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

4

Coated Caplets*

*Capsule-Shaped Tablets

[CVP® HEALTH logo]

Inactive Ingredients (Inactive ingredients)

calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

When Using This Product (When using this product)
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • 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
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland
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
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • 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 Pm, 6ct, Lil' Drug Store ® (Advil PM, 6ct, Lil' Drug Store ®)

Advil ® PM

Ibuprofen, 200 mg/

Diphenhydramine citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

6

Coated Caplets*

*Capsule-Shaped Tablets

[ Lil' Drug Store ® logo]

Advil Pm, 4ct Travel Basix Pdp/package (Advil PM, 4ct TRAVEL BASIX - PDP/Package)

Advil PM

Ibuprofen, 200 mg/

Diphenhydramine Citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

4

Coated Caplets*

*Capsule-Shaped Tablets

[TRAVEL BASIX logo]

Advilpm 30pc Dispens It Box, Lil' Drug Store ® (AdvilPM 30pc Dispens-It Box, Lil' Drug Store ®)

AdvilPM

Ibuprofen, 200 mg/

Diphenhydramine citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

For relief of occasional

sleeplessness when

associated with minor aches and pains

Helps you fall asleep

and stay asleep

See full Drug Facts information

on the back of this dispenser

30 PACKETS OF 2 COATED CAPLETS EACH*

*Capsule-Shaped Tablets

[Lil' Drug Store® logo]

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers, or any other sleep-aid
  • under a doctor's care for any continuing medical illness
  • taking any other antihistamines
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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