NDC 76281-327 Childrens Pain And Fever

Acetaminophen

NDC Product Information

Childrens Pain And Fever with NDC 76281-327 is a a human over the counter drug product labeled by Aptapharma Inc.. The generic name of Childrens Pain And Fever is acetaminophen. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Aptapharma Inc.

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 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 (UNII: 506T60A25R)
  • 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.

Product Labeler Information

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

Labeler Name: Aptapharma Inc.
Labeler Code: 76281
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: 05-04-2021 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".

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Childrens 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

Otc - Active Ingredient

Drug FactsActive 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 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 dailyamount • with other drugs containing acetaminophenAllergy alert: Acetaminophen may cause severe skin reactions.Symptoms may include: • skin reddening • blisters • rashIf skin reaction occurs, stop use and seek medical help right away.Sore throat warning If sore throat is severe, persists for morethan 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 drug containing acetaminophen(prescription or nonprescription). If you are not sure whetheradrug contains acetaminophen, ask a doctor or pharmacist.• if your child is allergic to acetaminophen or any of theinactive ingredlents 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 Istaking the blood thinning drug warfarin.

  • Pain gets worseor 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 - 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 • new symptomsoccur • redness or swelling is presentThese could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) may canliver damage. In case of overdose, get medical help, or contacta Poison Control Center right away. (1-800-222-1222.)Quick medical attention is critical for adults as well as childreneven if you do not notice any signs or symptoms.

Dosage & Administration

  • Directionsthis product does not contain directions or complete warnings for adult use.shake well before usingmL = milliter; tsp = teaspoonfind right dose on chart below. If possible, use weight to dose; otherwise , use age.if needed, repeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursdo 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 specifically designed for use with this product. Do not use any other dosing device.

Other Information

  • Each 5 mL (1 tsp) contains: sodium 3 mgstore between 20°-25°C (68°-77°F)do not refrigerateKeep carton for full directions for use

Inactive Ingredient

Inactive ingredients anhydrous citric acid, butylparaben,FD&C red #40, flavor, glycerin, high fructose corn syrup,microcrystalline cellulose and carboxymethylcellulose sodium,propylene giycol, purified water, sodium benzoate, sorbitol solution,sucralose, xanthan gum

Questions?

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

Package Labeling

  • CVSHealth®Compare to the activeingredient in Children'sTylenol® Oral Suspension**Suspension LiquidNDC 76281-327-26Children's Pain &FeverACETAMINOPHEN160 mg / 5 mLPain reliever;Fever reducerFor ages 2 to 11 yearsFree of:Added alcoholAspirinIbuprofenCHERRY FLAVORUse ONLY Enclosed Dosing Cup8 FL OZ (237 mL)**This product is not manufactured or distrubutedby McNeil Consumer Healthcare, distributor ofChildren's Tylenol® Oral Suspension.Distributed by: CVS Pharmacy, Inc.One CVS Drive, Woonsocket, RI 02895© 2021 CVS/pharmacyCVS.com® 1-800-SHOP CVS V-37464                                                BX-125DO NOT USE IF PRINTED NECK BAND ISBROKEN OR MISSINGres

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