NDC 0573-0167 Advil Pm
Diphenhydramine Hcl, Ibuprofen Capsule, Liquid Filled Oral

Product Information

Advil Pm is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Advil Pm is diphenhydramine hcl, ibuprofen. The product's dosage form is capsule, liquid filled and is administered via oral form.

Product Code0573-0167
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Advil Pm
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Diphenhydramine Hcl, Ibuprofen
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormCapsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0573
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA021393
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-20-2005
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Advil Pm?


Product Characteristics

Color(s)BLUE (C48333 - CLEAR BLUE)
ShapeOVAL (C48345)
Size(s)15 MM
Imprint(s)ADVIL;PM
Score1

Product Packages

NDC 0573-0167-25

Package Description: 1 BOTTLE in 1 CARTON > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE

Price per Unit: $0.19851 per EA

NDC 0573-0167-26

Package Description: 1 BOTTLE in 1 CARTON > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 0573-0167-43

Package Description: 1 BOTTLE in 1 CARTON > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE

Price per Unit: $0.19851 per EA

NDC 0573-0167-44

Package Description: 1 BOTTLE in 1 CARTON > 50 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 0573-0167-55

Package Description: 1 BOTTLE in 1 CARTON > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE

Price per Unit: $0.19851 per EA

NDC 0573-0167-56

Package Description: 1 BOTTLE in 1 CARTON > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE

Product Details

What are Advil Pm Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
  • IBUPROFEN 200 mg/1 - A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS.

Advil Pm Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 901814 - ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral Capsule
  • RxCUI: 901814 - diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral Capsule

Advil Pm Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]
Ibuprofen

Ibuprofen is pronounced as (eye byoo' proe fen)
Why is ibuprofen medication prescribed?
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints)...
[Read More]

* Please review the disclaimer below.

Advil Pm Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients (In Each Capsule)



Diphenhydramine hydrochloride 25 mg

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

*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 capsules at bedtime
  • do not take more than 2 capsules in 24 hours

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)
  • protect from light

Inactive Ingredients



D&C red no. 33, FD&C blue no. 1, medium-chain triglycerides, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution


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

Distributed by: Pfizer, Madison, NJ 07940 USA


Principal Display Panel - 200 Mg/25 Mg Capsule Bottle Carton - Ndc 0573-0167-25



Advil® PM
LIQUI•GELS®

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

20
Liquid Filled
Capsules


Principal Display Panel - 200 Mg/25 Mg Capsule Bottle Label



Advil® PM
LIQUI•GELS
®

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

80
Liquid Filled
Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION


Principal Display Panel - 200 Mg/25 Mg Capsule Bottle Carton - Ndc 0573-0167-55



Great
Value

Advil®
PM

LIQUI•GELS®

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

80
Liquid Filled
Capsules


Principal Display Panel - 200 Mg/25 Mg Capsule Bottle Carton - Ndc 0573-0167-26



50%
MORE
FREE

10 Free
LIQUI•GELS®

Advil® PM
LIQUI•GELS®

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

30
Liquid Filled
Capsules


* Please review the disclaimer below.