NDC 50844-611 Ibuprofen Pm

Diphenhydramine Hydrochloride, Ibuprofen

NDC Product Code 50844-611

NDC CODE: 50844-611

Proprietary Name: Ibuprofen 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: Diphenhydramine Hydrochloride, Ibuprofen 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):
PURPLE (C48327 - BLUISH TINT)
Shape: OVAL (C48345)
Size(s):
15 MM
Imprint(s):
1007
Score: 1

NDC Code Structure

  • 50844 - L.n.k. International, Inc.

NDC 50844-611-19

Package Description: 1 BLISTER PACK in 1 CARTON > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Ibuprofen Pm with NDC 50844-611 is a a human over the counter drug product labeled by L.n.k. International, Inc.. The generic name of Ibuprofen Pm is diphenhydramine hydrochloride, ibuprofen. The product's dosage form is capsule, liquid filled and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 901814.

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.

Ibuprofen 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.


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)
  • GELATIN (UNII: 2G86QN327L)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • WATER (UNII: 059QF0KO0R)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SHELLAC (UNII: 46N107B71O)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: L.n.k. International, Inc.
Labeler Code: 50844
FDA Application Number: ANDA200888 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: 07-08-2013 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Information for Patients

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.

Ibuprofen Pm Product Label Images

Ibuprofen 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)*non steroidal anti-inflammatory drug

Purpose

Nighttime sleep-aidPain reliever

Uses

  • For relief of occasional sleeplessness when associated with minor aches and painshelps 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:rashfacial swellingblistershivesskin reddeningshockasthma (wheezing)If an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if youare age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant ) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have 3 or more alcoholic drinks  every day while using this producttake more or for a longer time than directed

Do Not Use

  • If you have ever had an allergic reaction to any other pain reliever/fever reducerunless you have time for a full night's sleepin children under 12 years of agewith any other product containing diphenhydramine, even one used on skinright before or after heart surgeryif you have sleeplessness without pain

Ask A Doctor Before Use If

  • If you have problems or serious side effects from taking pain relievers or fever reducersyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthmayou are taking a diureticyou have glaucomayou have a breathing problem such as emphysema or chronic bronchitisstomach bleeding warning applies to youyou 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-aidunder a doctor's care for any continuing medical illnesstaking any other antihistaminestaking any other drugtaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

When Using This Product

  • Drowsiness will occuravoid alcoholic drinksdo not drive a motor vehicle or operate machinerytake with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterpain gets worse or lasts more than 10 dayssleeplessness 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 areaany 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 directedadults and children 12 years and over: take 2 capsules at bedtimedo not take more than 2 capsules in 24 hours

Other Information

  • Each capsule contains: potassium 20 mgread all warnings and directions before use.Keep cartonstore at 20º-25ºC (68º-77ºF)protect from lightavoid excessive heat above 40ºC (104ºF)

Inactive Ingredients

Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, hydrolysed gelatin, medium chain triglyceride, opacode white ink, polyethylene glycol 600, potassium hydroxide, purified water.ingredients of opacode white ink: lecithin (soya), n-butyl alcohol, purified water, shellac glaze in ethanol, simethicone and titanium dioxide.

* Please review the disclaimer below.