NDC 0904-7014 Children Acetaminophen Oral Solution

Acetaminophen

NDC Product Code 0904-7014

NDC Product Information

Children Acetaminophen Oral Solution with NDC 0904-7014 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Children Acetaminophen Oral Solution is acetaminophen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Major Pharmaceuticals

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.

Children Acetaminophen Oral Solution 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)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: Major Pharmaceuticals
Labeler Code: 0904
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: 10-01-2019 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’.

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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]

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Children Acetaminophen Oral Solution Product Label Images

Children Acetaminophen Oral Solution 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

Active ingredient (per 5 mL teaspoonful)Acetaminophen 160 mg

Otc - Purpose

PurposePain Reliever/Fever Reducer

Indications & Usage

  • Usestemporarily relieves minor aches and pains due to:headachemuscular achesbackacheminor pain of arthritisthe common coldtoothachepremenstrual and menstrual crampstemporarily reduces fever

Warnings

  • WarningsLiver Warning: This product contains acetaminophen. Severe liver damage may occur if:adult takes more than 6 doses in 24 hours, which is the maximum daily amountchild takes more than 5 doses in 24 hours, which is the maximum daily amounttaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks everyday while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.Ask a doctor before use if you have liver disease.Ask a doctor before use if you are taking the blood thinning drug warfarin.When using this product: Do not exceed recommended dose.Stop use and ask a doctor ifpain gets worse or lasts more than 10 days in adultspain gets worse or lasts more than 5 days in children under 12 yearsfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is present. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Dosage & Administration

  • Directionsdo not take more than directedfind dose in chart belowif possible, use weight to dose, otherwise use agedosage may be repeasted every 4 hours, or as directed by a doctordo not give more than 5 doses in 24 hours Weight (lbs) under 24 24-35 36-4748-59  60-71 72-95 over 95Age (years)  under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adultDosage Teaspoonful (tsp)  consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL) 4 tsp (20 mL)

Inactive Ingredient

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

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