NDC 60687-571 Acetaminophen

Acetaminophen

NDC Product Code 60687-571

NDC 60687-571-37

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY (60687-571-53) > 10.15 mL in 1 CUP, UNIT-DOSE (60687-571-42)

NDC 60687-571-56

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY (60687-571-48) > 20.3 mL in 1 CUP, UNIT-DOSE (60687-571-24)

NDC Product Information

Acetaminophen with NDC 60687-571 is a a human over the counter drug product labeled by American Health Packaging. The generic name of Acetaminophen is acetaminophen. The product's dosage form is solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 307675.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.


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 BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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: American Health Packaging
Labeler Code: 60687
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: 07-01-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

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 10.15 mL cup) Acetaminophen, USP 325 mg(in each 20.30 mL cup) Acetaminophen, USP 650 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:
  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps
  • Temporarily reduces fever

Warnings (10.15 Ml Unit Dose Cups)

  • Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 unit dose cups (3,250 mg) in 24 hours for adults or 5 unit dose cups (1,625 mg) in 24 hours for children, which is the maximum daily amount for this product. Severe liver damage may occur if
  • Adult takes more than 10 unit dose cups (101.50 mL) in 24 hours
  • Child takes more than 5 unit dose cups (50.75 mL) in 24 hours, which is the maximum daily amount
  • Taken with other drugs containing acetaminophen
  • Adult has 3 or more alcoholic drinks every day while using this product.
  • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may includeskin reddening
  • Blisters
  • Rash
  • If a skin reaction occurs, stop use and seek medical help right away.

Warnings (20.30 Ml Unit Dose Cups)

  • Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 5 unit dose cups (3,250 mg) in 24 hours for adults, which is the maximum daily amount for this product. Severe liver damage may occur if
  • Adult takes more than 5 unit dose cups (101.50 mL) in 24 hours
  • Taken with other drugs containing acetaminophen
  • Adult has 3 or more alcoholic drinks every day while using this product.
  • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may includeskin reddening
  • Blisters
  • Rash
  • If 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.
  • If you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor

Before use if the user has liver disease.

Ask A Doctor Or Pharmacist Before Use If The User Is

Taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

  • Pain gets worse or last for more than 10 days in adults
  • Pain gets worse or last for more than 5 days in children under 12 years
  • Fever gets worse or lasts for more than 3 days
  • New symptoms occur
  • Redness or swelling is present
  • These could be signs of a serious condition.

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions (10.15 Ml Unit Dose Cups)

  • Do not take more than directed (see overdose warning)
  • Adults and children 12 years and overtake 2 unit dose cups (20.30 mL) every 4 to 6 hours while symptoms last
  • Do not take more than 10 unit dose cups (101.50 mL0 in 24 hours, unless directed by a doctor
  • Do not use for mor than 10 days unless directed by a doctor
  • Children 6 years to under 12 yearstake 1 unit dose cup (10.15 mL) every 4 to 6 hours while symptoms last
  • Do not take more than 5 unit does cups (50.75 mL) in 24 hours
  • Do not use for more than 5 days unless directed by a doctor
  • Children under 6 yearsask a doctor

Directions (20.30 Ml Unit Dose Cups)

  • Do not take more than directed (see overdose warning)
  • Adults and children 12 years and overtake 1 unit dose cups (20.30 mL) every 4 to 6 hours while symptoms last
  • Do not take more than 5 unit dose cups (101.50 mL0 in 24 hours, unless directed by a doctor
  • Do not use for mor than 10 days unless directed by a doctor
  • Children 6 years to under 12 yearsask a doctor

Other Information

  • Each 10.15 mL contains: sodium 33.5 mg
  • Each 22.30 mL contains: sodium 67 mg
  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
  • Protect from light
  • DO NOT USE IF SEAL IS BROKENThis drug product is supplied in 10.15 mL unit dose cups as:100 cups (10 x 10) NDC 60687-571-56
  • This drug product is supplied in 20.30 mL unit dose cups as:100 cups (10 x 10) NDC 60687-571-37

Inactive Ingredients

Anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial cherry flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin

Packaging Information

American Health Packaging unit dose cups (see
Other Information section) contain drug product from Woodfield Pharmaceutical LLC as follows:

(325 mg per 10.15 mL / 100UD) NDC 60687-571-56 packaged from NDC 72207-114

(650 mg per 20.30 mL / 100UD) NDC 60687-571-37 packaged from NDC 72207-114
Distributed by:

American Health Packaging

Columbus, Ohio 43217
8457156/0621F

8457137/0621F

* Please review the disclaimer below.