NDC 70518-2168 Rugby Acetaminophen

Acetaminophen

NDC Product Code 70518-2168

NDC Code: 70518-2168

Proprietary Name: Rugby Acetaminophen 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):
10 MM
Imprint(s):
325MG;L403
Score: 1

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-2168-0

Package Description: 30 TABLET in 1 BLISTER PACK

NDC Product Information

Rugby Acetaminophen with NDC 70518-2168 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Rugby Acetaminophen is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Remedyrepack Inc.

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.

Rugby Acetaminophen 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 325 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • POVIDONE (UNII: FZ989GH94E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Remedyrepack Inc.
Labeler Code: 70518
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: 06-28-2019 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.

Rugby Acetaminophen Product Label Images

Rugby Acetaminophen 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 Ingredient (In Each Tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:
  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps
  • Temporarily reduces fever

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if
  • Adult takes more than 4,000 mg of acetaminophen in 24 hours
  • Child takes more than 5 doses in 24 hours
  • Taken with other drugs containing acetaminophen
  • Adult has 3 or more alcoholic drinks every day while using this product
  • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddening
  • Blisters
  • Rash
  • If a skin reaction occurs, stop use and seek medical help right away.

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.
  • If the user has ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If The User

  • Has liver disease
  • Is a child with pain of arthritis

Ask A Doctor Or Pharmacist Before Use If The User Is

Taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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.

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 (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 directed (see overdose warning)adults and children 12 years and overtake 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 10 tablets in 24 hours
  • Do not use for more than 10 days unless directed by a doctor
  • Children 6-11 yearstake 1 tablet every 4 to 6 hours while symptoms last
  • Do not take more than 5 tablets in 24 hours
  • Do not use for more than 5 days unless directed by a
  • Doctor
  • Children under 6 yearsask a doctor

Inactive Ingredients

Croscarmellose sodium*, povidone, pregelatinized starch, stearic acid*may contain this ingredient

* Please review the disclaimer below.