NDC 51672-2114 Feverall Infants

Acetaminophen

NDC Product Code 51672-2114

NDC 51672-2114-2

Package Description: 6 BLISTER PACK in 1 CARTON > 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0)

NDC 51672-2114-4

Package Description: 50 BLISTER PACK in 1 CARTON > 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0)

NDC Product Information

Feverall Infants with NDC 51672-2114 is a a human over the counter drug product labeled by Taro Pharmaceuticals U.s.a. Inc.. The generic name of Feverall Infants is acetaminophen. The product's dosage form is suppository and is administered via rectal form.

Labeler Name: Taro Pharmaceuticals U.s.a. Inc.

Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.

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.

Feverall Infants 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.

  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Taro Pharmaceuticals U.s.a. Inc.
Labeler Code: 51672
FDA Application Number: NDA018337 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: NDA - A product marketed under an approved New Drug Application. 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: 12-12-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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’.

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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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Feverall Infants 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

Drug Facts

  • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrash

Distributed by:Taro Pharmaceuticals U.S.A., Inc.Hawthorne, NY 10532

Active Ingredient (In Each Rectal Suppository)

Acetaminophen, USP 80 mg

Purposes

Pain reliever/fever reducer

Uses

  • Temporarilyreduces feverrelieves minor aches, pains, and headache

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if your child takesmore than 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 monthsmore than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 monthswith other drugs containing acetaminophen

Otc - Stop Use

If a skin reaction occurs, stop use and seek medical help right away.For rectal use only.

  • Stop use and ask a doctor iffever lasts more than 3 days (72 hours), or recurs.pain lasts more than 3 days or gets worse.new symptoms occur.redness or swelling is present in the painful area.These may be signs of a serious condition.

Do Not Use

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

Otc - Ask Doctor

  • Ask a doctor before use ifthe child has liver disease.the child is taking the blood thinning drug warfarin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Directions

  • This product does not contain directions or warnings for adult usedo not use more than directedremove wrappercarefully insert suppository well up into the rectumDosing ChartAgeDoseunder 6 monthsDo not use unless directed by a doctor6 to 11 monthsUse 1 suppository every 6 hours (maximum of 4 doses in 24 hours)12 to 36 monthsUse 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Other Information

  • Store at 2°-27°C (35°-80°F)do not use if imprinted suppository wrapper is opened or damaged

Inactive Ingredients

Glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80

Questions?

Call 1-866-923-4914

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