NDC 58602-814 Diphenhydramine Hcl And Ibuprofen

Diphenhydramine Hcl And Ibuprofen

NDC Product Code 58602-814

NDC Code: 58602-814

Proprietary Name: Diphenhydramine Hcl And Ibuprofen 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 Hcl And 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):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
15 MM
Imprint(s):
DHI25
Score: 1

NDC Code Structure

  • 58602 - Aurohealth Llc
    • 58602-814 - Diphenhydramine Hcl And Ibuprofen

NDC 58602-814-10

Package Description: 1 BOTTLE in 1 CARTON > 32 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 58602-814-12

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

NDC 58602-814-18

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

NDC 58602-814-23

Package Description: 120 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 58602-814-30

Package Description: 160 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 58602-814-73

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

NDC Product Information

Diphenhydramine Hcl And Ibuprofen with NDC 58602-814 is a a human over the counter drug product labeled by Aurohealth Llc. The generic name of Diphenhydramine Hcl And Ibuprofen is diphenhydramine hcl and ibuprofen. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Aurohealth Llc

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.

Diphenhydramine Hcl And Ibuprofen 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
  • IBUPROFEN 200 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.

  • 1,4-SORBITAN (UNII: AV0YTZ4E6J)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)
  • HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MANNITOL (UNII: 3OWL53L36A)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • POVIDONE K30 (UNII: U725QWY32X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • 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: Aurohealth Llc
Labeler Code: 58602
FDA Application Number: ANDA210676 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: 02-14-2019 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.

Diphenhydramine Hcl And Ibuprofen 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

Drug Facts

Active ingredients (in each capsule)Diphenhydramine hydrochloride USP 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen USP (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 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:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf 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 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.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 reducerunless you have time for a full night's sleepin children under 12 years of ageright before or after heart surgerywith any other product containing diphenhydramine, even one used on skinif you have sleeplessness without pain

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to youyou 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, asthma, or had a strokeyou are taking a diureticyou have a breathing problem such as emphysema or chronic bronchitisyou have glaucomayou 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 aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirintaking any other drug

When Using This Product

  • Drowsiness will occuravoid alcoholic drinksdo not drive a motor vehicle or operate machinerytake 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 faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain 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. [1-800-222-1222]

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 hoursOther informationeach capsule contains: potassium 20 mgread all warnings and directions before use. Keep carton.store at 20° to 25°C (68° to 77°F)avoid excessive heat above 40°C (104°F)protect from lightOrganic Impurities Test is PendingUSP Dissolution Test is pending

Inactive Ingredients

D&C Red No.33, gelatin, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polyethylene glycol, propylene glycol, potassium hydroxide, povidone, purified water, sorbital sorbitan solution, titanium dioxide. Questions or comments? Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)Distributed by:AUROHEALTH LLC2572 Brunswick PikeLawrenceville, NJ 08648Made in India Code No.: TS/DRUGS/22/2009

* Please review the disclaimer below.

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