NDC 0363-0322 Childrens Pain And Fever Cherry Flavor

Acetaminophen

NDC Product Code 0363-0322

NDC Product Information

Childrens Pain And Fever Cherry Flavor with NDC 0363-0322 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Childrens Pain And Fever Cherry Flavor is acetaminophen. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Walgreen Company

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.

Childrens Pain And Fever Cherry Flavor 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 160 mg/5mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.

Product Labeler Information

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

Labeler Name: Walgreen Company
Labeler Code: 0363
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: 11-05-2020 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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Childrens Pain And Fever Cherry Flavor Product Label Images

Childrens Pain And Fever Cherry Flavor 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

Otc - Active Ingredient

Active ingredient(in each 5 mL = 1 teaspoonful)Acetaminophen 160 mg

Otc - Purpose

PurposePain reliever/fever reducer

Indications & Usage

Uses temporarily ■ reduces fever■ relieves minor aches and pains due to:■ the common cold ■ flu ■ headache ■ sore throat■ toothache

Warnings

WarningsLiver warningThis product contains acetaminophen. Severe liverdamage may occur nyour child takes: ■ more than 5doses in 24 hours, which is the maximum daily amount■ with other drugs containing acetaminophenAllergy alert: acetaminophen may cause severe skinreactions. Symptoms may include: ■ skin reddening■ blisters ■ rashIf a skin reaction occurs, stop use and seek medical helpright away.Sore throat warningIf sore throat is severe, persists for more than 2 days,is accompanied or followed by ever, headache, rash.nausea or vomiting, consult a doctor promptly.

Otc - Do Not Use

Do not use■ with any other drug containing acetaminophen(prescription or nonprescription). If you are not surewhether a drug contains acetaminophen, ask a doctoror pharmacist.■ If your child is allergic to acetaminophen or any other ofthe 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 exceedrecommended dose (see overdose warning)

Otc - Stop Use

Stop use and ask a doctor if■ pain gets worse or lasts more than 5 days ■ fevergets worse or lasts more than 3 days ■ newsymptoms ■ redness or swelling is present.These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

Overdose warningTaking more than the recommended dose (overdose)may cause liver damage. In case of overdose, getmedical help or contact a Poison Control Center rightaway. (1-800-222-1222) Quick medical attention is criticalfor adults as well as for children even if youdo not notice any signs or symptoms.

Dosage & Administration

Directions■ this product does not contain directions or   complete warnings for adult use.■ shake well before using■ mL = milliliter; tsp = teaspoonful■ find the right dose on the chart below. If possible, use   weight to dose, otherwise, use age.■ if needed, repeat dose every 4 hours while   symptoms last■ do not give more than 5 times in 24 hours■ do not give for more than 5 days unless directed  by a doctor. Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2 - 3 years 5 mL (1 tsp) 36-47 4 - 5 years 7.5 mL (1 1/2 tsp) 48-59 6 - 8 years 10 mL (2 tsp) 60-71 9 - 10 years 12.5. mL (2 1/2 tsp) 72-95 11 years 15 mL (3 tsp)*or as directed by a doctorAttention: use only enclosed dosing cup specificallydesigned for use with this product. Do not use anyother dosing device.

Other Safety Information

Other information■ each 5 mL (1 tsp) contains; sodium 3 mg■ store between 20-25ºC (68-77ºF)■ do not refrigerate■ Keep carton for full directions for use.

Inactive Ingredient

Inactive ingredients Anhydrous citric acid,butylparaben, FD&C red #40 flavor, glycerin, highfructose corn syrup, microcrystalline cellulose andcarboxymethylcellulose sodium, propylene glycol,purified water. sodium benzoate, sorbitol solution,sucralose, xanthan gum

Otc - Questions

Questions? Call weekdays from 9:30 AM to 4:30PM EST at 1-877-798-5944

Product Label

WalgreensCompare to Children's Tylenol®Oral Suspension active ingredient††NDC 0363-0322-24children'sPain & FeverACETAMINOPHEN160 mg PER 5 mLPAIN RELIEVER /FEVER REDUCERORAL SUSPENSIONALCOHOL FREEASPIRIN FREEIBUPROFEN FREEAGES2-11YEARSCHERRY FLAVOR4 FL OZ (118 mL)This product is bot manufactured or distributed by Johnson& Johnson Consumer Inc., |McNeil Consumer Healthcare,distributor of Children's Tylenol® Oral Suspension.ITEM 268958 W00000-0000-0REV-1020DO NOT USE IF PRINTED NECKBAND ISBROKEN OR MISSINGWalgreens Pharmacist RecommendedWalgreens Pharmacist SurveyDISTRIBUTED BY WALGREEN CO.200 WILMONT RD., DEERFIELD, IL 60015100% SATISFACTION GUARANTEEDwalgreens.com ©2020 Walgreen Co.DOSAGECUP PROVIDED             BX-113ORG1020-FCartonBottleres

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