NDC 68016-243 Infants Pain Relief Oral Suspension Cherry Flavor

Acetaminophen

NDC Product Code 68016-243

NDC 68016-243-02

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

NDC Product Information

Infants Pain Relief Oral Suspension Cherry Flavor with NDC 68016-243 is a a human over the counter drug product labeled by Pharmacy Value Alliance, Llc. The generic name of Infants Pain Relief Oral Suspension Cherry Flavor is acetaminophen. The product's dosage form is suspension and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 307668.

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.

Infants Pain Relief Oral Suspension 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.


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)
  • MICROCRYSTALLINE CELLULOSE (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: Pharmacy Value Alliance, Llc
Labeler Code: 68016
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: 10-01-2018 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 - 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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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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Infants Pain Relief Oral Suspension Cherry Flavor Product Label Images

Infants Pain Relief Oral Suspension 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)       Acetaminophen 160 mg

Otc - Purpose

Purpose      Pain 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. Severeliver 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 skinreactions. Symptoms may include:■ skin reddening ■ blisters ■ rash.If a skin reaction occurs, stop use and seek medical help rightaway.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 (prescriptionor nonprescription). If you are not sure whether a drugcontains acetaminophen, ask a doctor or pharmacist■ if your child is allergic to acetaminophen or any of theinactive 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 takingthe blood thinning drug warfarin

Otc - When Using

When using this product do not exceed recommended dose(see overdose warning)

Otc - Stop Use

Stop use and ask a doctor if■ pain gets worse or lasts more than 5 days■ fever gets worse or lasts more than 3 days■ new symptoms occur■ redness or swelling is presentThese could be signs of a serious condition.

Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

Overdose warningIn case of overdose, get medical help or contact a PoisonControl Center right away. (1-800-222-1222) Quick medicalattention is critical for 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■ find right dose on 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.Dosing Chart Weight (lb)Age (yr) Dose (mL)*Under 24 Under 2 years Ask a doctor 24 -35 2 -3 years 5 mL*or as directed byAttention: use only enclosed dosingsyringe specifically designed for usewith this product. Do not use any otherdosing device.

Other Safety Information

Other information■ each 5 ml contains: sodium 3 mg■ store between 20-25°C (68-77oF)■ do not refrigerate

Inactive Ingredient

Inactive ingredientsanhydrous citric acid, butylparaben,FD&C red #40, flavor, glycerin, highfructose corn syrup, microcrystallinecellulose and carboxymethylcellulosesodium, propylene glycol, purified water,sodium benzoate, sorbitol solution,sucralose, xanthan gum

Otc - Questions

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

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