NDC 61919-271 Extra Strength Pain Relief

Acetaminophen

NDC Product Code 61919-271

NDC Code: 61919-271

Proprietary Name: Extra Strength Pain Relief 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 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):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
M2A457344
Score: 1

NDC Code Structure

  • 61919 - Direct Rx
    • 61919-271 - Extra Strength Pain Relief

NDC 61919-271-50

Package Description: 50 TABLET in 1 BOTTLE

NDC 61919-271-60

Package Description: 60 TABLET in 1 BOTTLE

NDC 61919-271-71

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Extra Strength Pain Relief with NDC 61919-271 is a a human over the counter drug product labeled by Direct Rx. The generic name of Extra Strength Pain Relief is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Direct Rx

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Extra Strength Pain Relief 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.

  • ACETAMINOPHEN 500 mg/1
  • ACETAMINOPHEN 500 mg/1
  • ACETAMINOPHEN 500 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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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.
  • Oral - Administration to or by way of the mouth.
  • 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: Direct Rx
Labeler Code: 61919
FDA Application Number: part343 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-14-2018 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: 12-31-2019 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.

Extra Strength Pain Relief Product Label Images

Extra Strength Pain Relief 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

Otc - Active Ingredient

Acetaminophen 500 mg

Otc - Purpose

Pain Reliever/Fever Reducer

Otc - When Using

Temporarily relieves minor aches and pains

temporarily reduces fever

Do not take more than directed

adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours

children under 12 years: do not use

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you takemore than 8 tablets in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product
Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.Ask a doctor before use if you haveliver disease.Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.Stop use and ask a doctor ifpain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptom occur

redness or swelling is present
These could be signs of a serious condition.If pregnant or breast-feeding, ask a health professional before use.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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Keep out of reach of children.

Other Safety Information

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

store at 20⁰C-25⁰C (68⁰F-77⁰F)

for institutional use only

Inactive Ingredient

Povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben

* Please review the disclaimer below.

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