NDC 0295-1312 Pediacare Childrens Fever Reducer Pain Reliever Cherry

Acetaminophen

NDC Product Code 0295-1312

NDC Code: 0295-1312

Proprietary Name: Pediacare Childrens Fever Reducer Pain Reliever Cherry Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 0295 - Denison Pharmaceuticals, Llc
    • 0295-1312 - Pediacare Childrens Fever Reducer Pain Reliever Cherry

NDC 0295-1312-12

Package Description: 59 mL in 1 BOTTLE

NDC Product Information

Pediacare Childrens Fever Reducer Pain Reliever Cherry with NDC 0295-1312 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Pediacare Childrens Fever Reducer Pain Reliever Cherry is acetaminophen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Denison Pharmaceuticals, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Pediacare Childrens Fever Reducer Pain Reliever Cherry Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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.

  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Denison Pharmaceuticals, Llc
Labeler Code: 0295
FDA Application Number: part343 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-07-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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’.

* Please review the disclaimer below.

Pediacare Childrens Fever Reducer Pain Reliever Cherry Product Label Images

Pediacare Childrens Fever Reducer Pain Reliever Cherry 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:
  • The common coldfluheadachesore throattoothache

Warnings

  • Liver warning: This product contains acetaminophen. Sever 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 reddening  blisters  rashIf 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.

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 the child is allergic to acetaminophen or any of the inactive ingredients in this productAsk a doctor before use if the child has liver disease.
  • Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.
  • When using this product
  • Do not exceed recommended dosage (see overdose warning)

Stop Use And Ask A Doctor If

  • Pain 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.

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.
  • Shake well before using.   find right dose on chart below. If possible, use weight to determine dose; otherwise, use age.  only use the enclosed syringe
  • Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.  remove cap and insert syringe into hole at top of bottle and turn upside down.  pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back in 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 symptoms last  do not use more than 5 times in 24 hours (see overdose warning)  do not give more than 5 days unless directed by a doctor  replace cap tightly to maintain child resistance  ml = millilitre Weight (lbs) Age (yrs) Dose (mL)                   under 24
  • Under 2 years
  • Ask a doctor
  • 24-35
  • 2-3 years
  • 5 ml

Other Information

  • Store at 20-25˚C (68-77˚F)
  • Tamper evident: do not use if printed seal on bottle is broken or missing

Inactive Ingredients

Citric acid , FD&C red no.40, flavors, glycerine, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum

Questions

1-888-474-3099 Monday – Friday 8 am – 5 pm eastern standard time   PediCare.com

* Please review the disclaimer below.

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