Percogesic Extra Strength
Acetaminophen And Diphenhydramine
Medtech Products Inc.
Human Otc Drug
NDC 63029-049Percogesic Extra Strength also known as Acetaminophen And Diphenhydramine is a human otc drug labeled by 'Medtech Products Inc.'. National Drug Code (NDC) number for Percogesic Extra Strength is 63029-049. This drug is available in dosage form of Capsule, Coated. The names of the active, medicinal ingredients in Percogesic Extra Strength drug includes Acetaminophen - 500 mg/1 Diphenhydramine - 12.5 mg/1 . The currest status of Percogesic Extra Strength drug is Active.
Drug Information:
| Drug NDC: | 63029-049 |
| 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: | Percogesic Extra Strength |
| 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 And Diphenhydramine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medtech Products Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Coated |
| 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 - 500 mg/1
DIPHENHYDRAMINE - 12.5 mg/1
|
| 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: | 07 Jul, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 2026 |
| 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: | 31 Dec, 2023 |
| 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: | Medtech Products Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000000190
N0000175587
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 362O9ITL9D
8GTS82S83M
|
| 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. |
| Pharmacologic Class MOA: | Histamine H1 Receptor Antagonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Histamine-1 Receptor Antagonist [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63029-049-13 | 1 BOTTLE, PLASTIC in 1 BOX (63029-049-13) / 60 CAPSULE, COATED in 1 BOTTLE, PLASTIC | 07 Jul, 2010 | N/A | No |
| 63029-049-40 | 1 BOTTLE, PLASTIC in 1 BOX (63029-049-40) / 40 CAPSULE, COATED in 1 BOTTLE, PLASTIC | 24 Jul, 2010 | N/A | 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 antihistamine
Product Elements:
Percogesic extra strength acetaminophen and diphenhydramine acetaminophen acetaminophen diphenhydramine diphenhydramine croscarmellose sodium fd&c yellow no. 6 hypromellose, unspecified magnesium stearate cellulose, microcrystalline mineral oil silicon dioxide stearic acid talc titanium dioxide triacetin esp
Indications and Usage:
Uses for temporary relief of minor aches and pains due to: heqadache backache muscular aches arthritis pain colds flu fever toothache premenstrual and menstrual cramps temporarily relieves runny nose sneezing itchy nose and throat
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 6 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma ask a doctor or pharmacist before u
Read more...se if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause drowsiness may cause excitability, especially in children be careful driving a motor vehicle or operating machinery stop use and ask a doctor if pain persists for more than 10 days fever persists for more than 3 days (unless directed by a doctor) condition worsens or new symptoms occur redness or swelling is present. these may be signs of a serious condition. if you are pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than the recommeded dose (overdose) could cause seroius health problems, including liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. do not exceed recommended dosage.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 6 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause drowsiness may cause excitability, especially in children be careful driving a motor vehicle or operating machinery stop use and ask a doctor if pain persists for more than 10 days fever persists for more than 3 days (unless directed by a doctor) condition worsens or new symptoms occur redness or swelling is present. these may be signs of a serious condition. if you are pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than the recommeded dose (overdose) could cause seroius health problems, including liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. do not exceed recommended dosage.
When Using:
When using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause drowsiness may cause excitability, especially in children be careful driving a motor vehicle or operating machinery
Dosage and Administration:
Directions adults and children 12 years of age and older: take 2 tablets every 6 hours. maximum daily dose is 6 tablets. children under 12 years of age: ask a doctor.
Stop Use:
Stop use and ask a doctor if pain persists for more than 10 days fever persists for more than 3 days (unless directed by a doctor) condition worsens or new symptoms occur redness or swelling is present. these may be signs of a serious condition.
Overdosage:
Overdose warning taking more than the recommeded dose (overdose) could cause seroius health problems, including liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. do not exceed recommended dosage.
Package Label Principal Display Panel:
Principal display panel extra strength percogesic, acetaminophen / diphenhydramine 60 coated tablets percogesic extra strength 60 ct carton
Principal display panel extra strength percogesic, acetaminophen / diphenhydramine 40 coated tablets percogesic extra strength 40 ct carton
Further Questions:
Questions? 1-800-443-4908