NDC 0536-1014 Pain And Fever

Acetaminophen

NDC Product Code 0536-1014

NDC 0536-1014-07

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Pain And Fever with NDC 0536-1014 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Pain And Fever is acetaminophen. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Rugby Laboratories

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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 And Fever 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 80 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.

  • ASPARTAME (UNII: Z0H242BBR1)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • POVIDONES (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • SORBITOL (UNII: 506T60A25R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Rugby Laboratories
Labeler Code: 0536
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: 12-01-2013 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: 05-31-2021 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".

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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]

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Pain And Fever Product Label Images

Pain And Fever 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

Other

SAVE CARTON FOR COMPLETE DRUG FACTSDrug Facts

Distributed by:
Rugby Laboratories17177 N. Laurel Park Drive, Suite 233Livonia, MI 48152www.rugbylaboratories.comDO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Otc - Active Ingredient

Active ingredient (in each chewable tablet)Acetaminophen 80 mg

Otc - Purpose

PurposesPain Reliever/Fever Reducer

Indications & Usage

  • Usestemporarily relieves minor aches and pains due to:the common coldfluheadachesore throattoothachetemporarily reduces fever.

Warnings

  • WarningsLiver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
  • More than 5 doses in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophenAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Otc - Do Not Use

  • Do not use with any other other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

Otc - When Using

When using this product,do not exceed recommended dose (see overdose warning).

Otc - Stop Use

  • Stop use and ask a doctor ifpain gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Dosage & Administration

  • Directionsthis product does not contain directions or warnings for adult use.find right dose on chart below. If possible, use weight to dose; otherwise use age.chew before swallowingif needed, repeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursdo not give more than 5 days unless directed by a doctorWeightAgeDosageUnder 24 lbsUnder 2 yearsAsk a doctor24-35 lbs2-3 years2 tablets36-47 lbs4-5 years3 tablets48-59 lbs6-8 years4 tablets60-71 lbs9-10 years5 tablets72-95 lbs11 years6 tablets

Storage And Handling

  • Other informationPhenylketonurics: Contains Phenylalanine 14 mg per tabletStore at room temperature in a dry place

Inactive Ingredient

Inactive ingredients Aspartame, Colloidal Silicon Dioxide, D&C Red #27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural and Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

Otc - Questions

Questions or comments? Call 1-800-645-2158

* Please review the disclaimer below.