NDC 71399-0160 Acetaminophen

Acetaminophen

NDC Product Information

Acetaminophen with NDC 71399-0160 is a a human over the counter drug product labeled by Akron Pharma Inc.. The generic name of Acetaminophen is acetaminophen. The product's dosage form is elixir and is administered via oral form.

Labeler Name: Akron Pharma Inc.

Dosage Form: Elixir - A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.

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.

Acetaminophen 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: Akron Pharma Inc.
Labeler Code: 71399
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: 10-25-2019 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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Acetaminophen Product Label Images

Acetaminophen 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 = 1 Teaspoonful)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

  • To reduce fever and for the temporary relief of minor aches and pains due to:headache muscular aches backache minor pain of arthritis the common coldtoothache premenstrual and menstrual cramps. Temporarily reduces fever.

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur ifadult 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 amount taken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks everyday while using this product.

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor

  • Ask a doctor before use if your child has liver diseaseis on a sodium-restricted diet.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Otc - When Using

When using this product: Do not exceed recommended dose

Stop Use And Ask A Doctor If:

  • Pain gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 days new symptoms occur.redness 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.

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 right away. Quick medicalattention is critical for adults/children even if you do not notice any signs or symptoms.

Directions

  • Shake well before usingfind the right dose on chart below, if possible, use weight to dose; otherwise use agedosage may be repeated every 4 hours, or as directed by your doctordo not use more than 5 doses in 24 hoursdo not use more than 5 days unless directed by a doctor.find right dose on chart below, If possible, use weight to dose; otherwise, use age.Weight (lbs.)          Age (years)             dosage-teaspoonful (tsp.) under 24 under 2 consult Physician 24 to 35 2 to 3 1 tsp. (5 mL) 36 to 47 4 to 5 1 1/2 tsp. (7.5 mL) 48 to 59 6 to 8 2 tsp. (10 mL) 60 to 71 9 to 10 2 1/2 tsp. (12.5 mL) 72 to 95 11 3 tsp. (15 mL)

Other Information

  • Store at room temperature 15°-30° C (59°-86°F)Protect from Freezing. Protect from Light.

Other

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive Ingredients:

Bubble Gum Flavor, Citric Acid, FD C RED #40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.Questions or Comments?Call (877) 225-6999 Monday - Friday 9AM-5PM ESTManufactured forAkron Pharma, Inc.,Fairfeld, NJ - 07004Rev 09-19Manufactured In USA* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir

* Please review the disclaimer below.