NDC 63941-321 Infants Pain And Fever

Acetaminophen

NDC Product Code 63941-321

NDC 63941-321-04

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 59 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Infants Pain And Fever with NDC 63941-321 is a a human over the counter drug product labeled by Best Choice (valu Merchandisers Company). The generic name of Infants Pain And Fever is acetaminophen. The product's dosage form is suspension and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 307668.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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.

Infants 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.


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.

  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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: Best Choice (valu Merchandisers Company)
Labeler Code: 63941
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: 10-31-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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 - 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]

* Please review the disclaimer below.

Infants Pain And Fever Product Label Images

Infants 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

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily reduces fevertemporarily relieves minor aches and pains due to:fluthe common coldheadachesore throattoothache

Warnings

  • Liver 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 amount with 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 awaySore 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.

Do Not Use

  • With any 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.

Ask A Doctor Before Use If Your Child Has

Liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is

Taking the blood thinning drug warfarin.

When Using This Product,

Do not exceed recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

  • New symptoms occurredness or swelling is presentpain gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 daysThese could be signs of a serious condition.

Keep Out Of Reach Of Children.

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • This product does not contain directions or complete warnings for adult use.do not take more than directed (see overdose warning)shake well before usingmL= milliliteronly use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your childremove cap, insert syringe into hole at top of bottle and turn upside downpull back syringe until filled to be prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek)If needed, repeat dose every 4 hours while syptoms lastdo not give more than 5 times in 24 hoursdo not give more than 5 days unless directed by a doctorreplace cap tightly to maintain child resistancefind the right dose on chart below. If possible, use weight to dose; otherwise, use ageWeight (lb)Age (year)  Dose (mL) under 24under 2 yearsask a doctor 24-35 2-3 years5 mL

Other Information

  • Store between 20-25ºC (68º-77ºF)do not refrigerate.see bottom panel for lot number and expiration date

Inactive Ingredients

Acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red #40, flavors, glycerin, high fructos corn syrup, microcrystalline cellulose, propylene glycol, purfied water, sodium benzoate, sorbitol, xanthan gum

Package Label

BEST CHOICE Infants' Pain & Fever

* Please review the disclaimer below.