NDC 36800-447 Pain Relief Pm Extra Strength

Acetaminophen, Diphenhydramine Hcl

NDC Product Code 36800-447

NDC CODE: 36800-447

Proprietary Name: Pain Relief Pm Extra Strength 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: Acetaminophen, 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: CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
S525;P525;G651
Score: 1

NDC Code Structure

  • 36800 - Top Care (topco Associates Llc)

NDC 36800-447-50

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 50 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Product Information

Pain Relief Pm Extra Strength with NDC 36800-447 is a a human over the counter drug product labeled by Top Care (topco Associates Llc). The generic name of Pain Relief Pm Extra Strength is acetaminophen, diphenhydramine hcl. The product's dosage form is tablet, coated and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1092189.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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 Extra Strength 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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • POVIDONE K30 (UNII: U725QWY32X)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • WATER (UNII: 059QF0KO0R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)

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: Top Care (topco Associates Llc)
Labeler Code: 36800
FDA Application Number: part341 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-31-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-31-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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

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.

Pain Relief Pm Extra Strength Product Label Images

Pain Relief Pm Extra Strength 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 Caplet)

Acetaminophen 500 mgDiphenhydramine HCl 25 mg

Purpose

Pain relieverNighttime sleep-aid

Uses

Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours
  • With other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddening
  • Blisters
  • Rash

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • With any other products containing diphenhydramine, even one used on skin
  • In children under 12 years of age

Ask A Doctor Before Use If You Have

  • Liver disease
  • A breathing problems such as emphysema or chronic bronchitis
  • Trouble urinating due to an enlarged 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.
  • New symptoms occur
  • Redness or swelling is present
  • Pain gets worse or lasts for more than 10 days
  • Fever gets worse or lasts for more than 3 days These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 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 directed (see overdose warning)adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
  • Children under 12 years: do not use

Other Information

  • Store at room temperature 15°-30°C (59°-86°F)
  • Avoid high humidity and excessive heat

Inactive Ingredients

Carnauba wax*, croscarmellose sodium*, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, polyvinyl alcohol*, povidone K30, pregelatanized starch, purified water*, silicon dioxide*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide*contains one or more of these ingredienrts

Package Label

TopCare Pain Relief PM

* Please review the disclaimer below.