NDC 59105-001 Acetaminophen And Diphenhydramine Hydrochloride

Product Information

What is NDC 59105-001?

The NDC code 59105-001 is assigned by the FDA to the product Acetaminophen And Diphenhydramine Hydrochloride which is product labeled by J.p. Business Enterprise. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 59105-001-24 1 bottle in 1 carton / 24 tablet, film coated in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code59105-001
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.
Acetaminophen And Diphenhydramine Hydrochloride
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
J.p. Business Enterprise
Labeler Code59105
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.
08-20-2013
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.
12-31-2020
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".
I
NDC Code Structure

What are the uses for Acetaminophen And Diphenhydramine Hydrochloride?


Product Characteristics

Color(s)BLUE (C48333)
ShapeOVAL (C48345)
Size(s)18 MM
Imprint(s)S525
Score1

Product Packages

NDC Code 59105-001-24

Package Description: 1 BOTTLE in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Acetaminophen And Diphenhydramine Hydrochloride 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: 1092189 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
  • RxCUI: 1092189 - APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet

Acetaminophen And Diphenhydramine Hydrochloride 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.

* Please review the disclaimer below.

Patient Education

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
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]

* Please review the disclaimer below.

Acetaminophen And Diphenhydramine Hydrochloride Product Label

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.

Product Label Table of Contents



Other



Drug Facts

Distributed By: J.P Business Enterprise Lake Grove, NY 11755


Otc - Purpose



Active ingredients (in each caplet)Purpose
Acetaminophen 500mgPain reliever
Diphenhydramine HCl 25mgNighttime Sleep aid

Uses



for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness


Liver Warning



This product contains acetaminophen. Severe liver damage may occur with this product if you take

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while you are using this product

Do Not Use



  • with other products containing acetaminophen (prescription or nonprescription).
  • If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

    • in children under 12 years of age
    • with any other products containing diphenhydramine, even one used on skin
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have



  • liver cirrhosis
  • asthma
  • breathing problems such as emphysema or chronic bronchitis
  • trouble in urinating due to an enlargement of the prostate gland
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When Using This Product



  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery.

Stop Use And Ask A Doctor If



  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • do not take more than recommended (see overdose warning)
  • adults and children 12 years of age and over:
    • take 2 caplets at bedtime or as directed by a doctor
    • do not take more than 2 caplets in a 24 hour period
    children under 12 years or age:
    • do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage

Other Information



  • store at 20°-25°C (68°-77°F)
  • see end panel for lot number and expiration
  • each tablet contains: magnesium 0.05 mg

Inactive Ingredients



FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide


Questions Or Comments?



1-888-333-9792


Principal Display Panel - 24 Caplet Bottle Carton



VALUMEDS

SEE NEW WARNINGS INFORMATION

Compare to the active ingredients
in TYLENOL ® PM *

EXTRA STRENGTH

PAIN RELIEF PM

PAIN RELIEVER • NIGHTTIME SLEEP AID

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

24 CAPLETS


* Please review the disclaimer below.