NDC 0295-9003 Little Remedies Infant Fever/pain Reliever Natural Grape Natural Grape

Acetaminophen

NDC Product Code 0295-9003

NDC Code: 0295-9003

Proprietary Name: Little Remedies Infant Fever/pain Reliever Natural Grape Natural Grape What 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 What 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, Inc.
    • 0295-9003 - Little Remedies Infant Fever/pain Reliever Natural Grape

NDC 0295-9003-12

Package Description: 1 BOTTLE in 1 CARTON > 59 mL in 1 BOTTLE

NDC 0295-9003-17

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Little Remedies Infant Fever/pain Reliever Natural Grape Natural Grape with NDC 0295-9003 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Inc.. The generic name of Little Remedies Infant Fever/pain Reliever Natural Grape Natural Grape is acetaminophen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Denison Pharmaceuticals, Inc.

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 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.


Little Remedies Infant Fever/pain Reliever Natural Grape Natural Grape 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)

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: Denison Pharmaceuticals, Inc.
Labeler Code: 0295
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: 04-18-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Little Remedies Infant Fever/pain Reliever Natural Grape Natural Grape Product Label Images

Little Remedies Infant Fever/pain Reliever Natural Grape Natural Grape 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 teaspoon)Active IngredientPurposeAcetaminophen 160mgPain Reliever/Fever Reducer

Purpose

Pain Reliever/Fever Reducer

Uses

  • Temporarily:Reduces feverRelieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.

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 acetaminophen.Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddining Blisters RashIf 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask A Doctor Before Use

If your child has liver disease.

Ask A Doctoror Pharmacist Before Use

If your child is taking the blood thinning drug warfarin.

Do Not Use:

  • With any other products 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.

When Using This Product,

  • DO NOT EXCEED RECOMMENDED DOSAGE (see overdose warning).

Stop Use And Ask A Doctor If:

  • New symptoms occur.Fever gets worse or lasts more than 3 days.Pain gets worse or lasts more than 5 days.Redness or swelling is present. These could be signs of a serious condition.

Overdosewarning:

Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Prompt medical attention is critical even if you do not notice any signs of symptoms.

Directions

  • This product does not contain directions or complete warnings for adult use. Do not give more than directed (see overdose warning).Shake well before using.Find the right dose on side panel. (If possible, use weight to determine dose; otherwise, use age.)Only use with enclosed AccuSafe ® syringeRemove cap, insert syringe to flow restrictor and invert bottlePull back syringe until filled to the prescribed level and slowly dispense the liquid into your child's mouth (towards the inner cheek)If needed, repeat dose every 4 hours while symptoms last.Do not give more than 5 days in any 24-hour periodReplace cap tightly to maintain child resistance. mL = mililiter Weight (lb)Age (yr)DoseUnder 24Under 2Ask a doctor24-352 – 35mL

Other Information

  • Each 5 mL contains: sodium 6 mg Store at 20-25ºC (68-77ºF)AccuSafe ® Oral dosing device enclosedCheck expiration date on bottle or box before using

Inactive Ingredients:

Benzoic acid, carboxymethylcellulose, glycerin, natural grape flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum

Questions?

For further information you may contact us at:


1-800-754-8853 Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST, or visit us at www.LittleRemedies.com.

* Please review the disclaimer below.

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