NDC 69452-264 Pain Relief Pm

Ibuprofen, Diphenhydramine Hcl

NDC Product Code 69452-264

NDC Code: 69452-264

Proprietary Name: Pain Relief Pm 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.

Non-Proprietary Name: Ibuprofen, Diphenhydramine Hcl 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.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
19 MM
Imprint(s):
IBUPM
Score: 1

NDC Code Structure

  • 69452 - Bionpharma Inc.
    • 69452-264 - Pain Relief Pm

NDC 69452-264-22

Package Description: 120 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC Product Information

Pain Relief Pm with NDC 69452-264 is a a human over the counter drug product labeled by Bionpharma Inc.. The generic name of Pain Relief Pm is ibuprofen, diphenhydramine hcl. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Bionpharma Inc.

Dosage Form: Capsule, 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.

Product Type: Human Otc Drug 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.

Pain Relief Pm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • IBUPROFEN 200 mg/1
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)

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.

Labeler Name: Bionpharma Inc.
Labeler Code: 69452
FDA Application Number: ANDA090397 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 05-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pain Relief Pm Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each Capsule)

Diphenhydramine hydrochloride 25 mgSolubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*(present as the free acid and potassium salt)*nonsteroidal anti-inflammatory drug

Purposes

Nighttime sleep-aidPain reliever

Uses

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

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■ blistersIf 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 directedHeart 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.■ store at 20° to 25°C (68° to 77°F)■ avoid excessive heat above 40°C (104°F)■ protect from light

Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

* Please review the disclaimer below.

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