Acetaminophen
American Health Packaging
Human Otc Drug
NDC 60687-571Acetaminophen is a human otc drug labeled by 'American Health Packaging'. National Drug Code (NDC) number for Acetaminophen is 60687-571. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Acetaminophen drug includes Acetaminophen - 160 mg/5mL . The currest status of Acetaminophen drug is Active.
Drug Information:
| Drug NDC: | 60687-571 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Acetaminophen |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | American Health Packaging |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACETAMINOPHEN - 160 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jul, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 30 Sep, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part343 |
| 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. |
| Listing Expiration Date: | 10 Jun, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | American Health Packaging
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 307675
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 362O9ITL9D
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 60687-571-37 | 10 TRAY in 1 CASE (60687-571-37) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-571-53) / 20.3 mL in 1 CUP, UNIT-DOSE (60687-571-24) | 01 Jul, 2021 | 30 Sep, 2023 | No |
| 60687-571-56 | 10 TRAY in 1 CASE (60687-571-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-571-48) / 10.15 mL in 1 CUP, UNIT-DOSE (60687-571-42) | 01 Jul, 2021 | 30 Sep, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose pain reliever/fever reducer
Product Elements:
Acetaminophen acetaminophen anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin methylparaben polyethylene glycol, unspecified propylparaben water sodium citrate, unspecified form saccharin sodium acetaminophen acetaminophen
Indications and Usage:
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:
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 include skin 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 include skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away.
Do Not Use:
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 include skin 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 include skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away.
Dosage and Administration:
Directions (10.15 ml unit dose cups) do not take more than directed (see overdose warning) adults and children 12 years and over take 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 years take 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 years ask a doctor
Directions (20.30 ml unit dose cups) do not take more than directed (see overdose warning) adults and children 12 years and over take 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 years ask a doctor
Stop Use:
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.
Package Label Principal Display Panel:
Package/label principal display panel - tray acetaminophen oral solution, usp pain reliever/fever reducer 325 mg/10.15 ml artificial cherry flavor for institutional use only 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. 8457156/0621f acetaminophen oral solution, usp pain reliever/fever reducer 650 mg/20.30 ml artificial cherry flavor for institutional use only 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. 8457137/0621f 325mg per 10.15ml acetaminophen oral solution label 650 mg per 20.30 ml acetaminophen oral solution label
Package/label principal display panel â cup â 325 mg per 10.15 ml ndc 60687- 571 -42 acetaminophen oral solution, usp pain reliever/fever reducer 325 mg/10.15 ml delivers 10.15 ml protect from light. see package drug facts insert for full prescribing information and storage. for institutional use only. american health packaging columbus, oh 43217 0457156/0620 325 mg per 10.15 ml acetaminophen oral solution cup
Package/label principal display panel â cup â 650 mg per 20.30 ml ndc 60687- 571 -24 acetaminophen oral solution, usp pain reliever/fever reducer 650 mg/20.30 ml delivers 20.30 ml protect from light. see package drug facts insert for full prescribing information and storage. for institutional use only. american health packaging columbus, oh 43217 0457137/0620 650 mg per 20.30 ml acetaminophen oral solution cup