Advil Pm Tablet, Coated
FDA Label NDC 0573-0164

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Advil Pm (NDC 0573-0164). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each caplet), purposes, uses, allergy alert:, stomach bleeding warning:, heart attack and stroke warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Caplet)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Nighttime sleep-aid

Pain reliever

Uses

  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep

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.

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

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

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

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

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

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.

Keep Out Of Reach Of Children.

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

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

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 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

For most recent product information, visit www.Advil.com.

Principal Display Panel - 20 Caplet Bottle Label

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

20
Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Principal Display Panel - 20 Caplet Bottle Carton

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

20
Coated Caplets*
*Capsule-Shaped Tablets

Principal Display Panel - 50 Caplet Bottle Label

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

50
Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Do Not Use if seal under bottle cap imprinted with
"SEALED for YOUR PROTECTION" is broken or missing.

Principal Display Panel - 50 Caplet Bottle Carton

25%
MORE
FREE

Advil®PM

10 Free
Caplets

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

50
Coated Caplets*
*Capsule-Shaped Tablets

Principal Display Panel - 2 Caplet Pouch

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

2 Caplets

Principal Display Panel - 50 Pouch Tray

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

Coated Caplets*
*Capsule-Shaped Tablets

Principal Display Panel - 120 Caplet Bottle Label

Easy Open
ARTHRITIS CAP

Arthritis Foundation
Ease of
Use℠

CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

120
Coated Caplets*
*Capsule-Shaped Tablets

Principal Display Panel - 8 Caplet Vial - Packed

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

8
Caplets

Principal Display Panel - 8 Caplet Vial Package

Home &
Travel

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

Do not use if blister is open or the words
"ADVIL SAFETY SEALED" under blister
are missing or torn.

8
Coated Caplets*
*Capsule-Shaped Tablets

Principal Display Panel - 8 Caplet Vial - Loose

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

8
Coated Caplets*
*Capsule-Shaped Tablets

* Please review the disclaimer below.