Goodys Pm
Acetaminophen And Diphenhydramine Citrate
Medtech Products Inc.
Human Otc Drug
NDC 63029-656Goodys Pm also known as Acetaminophen And Diphenhydramine Citrate is a human otc drug labeled by 'Medtech Products Inc.'. National Drug Code (NDC) number for Goodys Pm is 63029-656. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Goodys Pm drug includes Acetaminophen - 500 mg/1 Diphenhydramine Citrate - 38 mg/1 . The currest status of Goodys Pm drug is Active.
Drug Information:
| Drug NDC: | 63029-656 |
| 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: | Goodys Pm |
| 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 Citrate |
| 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: | Powder |
| 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 CITRATE - 38 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 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 Sep, 2013 |
| 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: | part341 |
| 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. |
| RxCUI: | 1297947
|
| 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. |
| UPC: | 0042037102951
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
4OD433S209
|
| 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: | 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 |
|---|
| 63029-656-06 | 6 POWDER in 1 CARTON (63029-656-06) | 01 Sep, 2013 | N/A | No |
| 63029-656-16 | 16 POWDER in 1 CARTON (63029-656-16) | 01 Sep, 2013 | 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:
Purposes pain reliever nighttime sleep-aid
Product Elements:
Goodys pm acetaminophen and diphenhydramine citrate acetaminophen acetaminophen diphenhydramine citrate diphenhydramine citric acid monohydrate docusate sodium fumaric acid lactose monohydrate magnesium stearate potassium chloride silicon dioxide sodium benzoate trisodium citrate dihydrate glycine
Indications and Usage:
Uses ⢠temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 4,000 mg of acetaminophen in 24 hours ⢠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: â skin reddening â blisters â 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. ⢠in children under 12 years of age ⢠with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have ⢠liver disease ⢠glaucoma ⢠a breathing problem such as emphysema or chronic bronchitis ⢠trouble urinating due to an enlarged prostate gland ask a doctor o
Read more...r pharmacist before use if you are taking ⢠the blood thinning drug warfarin ⢠sedatives or tranquilizers when using this product ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. ⢠pain gets worse or lasts more than 10 days ⢠redness or swelling is present ⢠any new symptoms appear 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: taking more than the recommended dose can cause serious health problems. in case of overdose, get medical help or contact poison control center (1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 4,000 mg of acetaminophen in 24 hours ⢠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: â skin reddening â blisters â 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. ⢠in children under 12 years of age ⢠with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have ⢠liver disease ⢠glaucoma ⢠a breathing problem such as emphysema or chronic bronchitis ⢠trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking ⢠the blood thinning drug warfarin ⢠sedatives or tranquilizers when using this product ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. ⢠pain gets worse or lasts more than 10 days ⢠redness or swelling is present ⢠any new symptoms appear 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: taking more than the recommended dose can cause serious health problems. in case of overdose, get medical help or contact poison control center (1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions ⢠do not take more than directed (see overdose warning ) ⢠adults and children 12 years of age and over: take 2 powders at bedtime, if needed, or as directed by a doctor. drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid. ⢠do not give to children under 12 years of age
Stop Use:
Stop use and ask a doctor if ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. ⢠pain gets worse or lasts more than 10 days ⢠redness or swelling is present ⢠any new symptoms appear these could be signs of a serious condition.
Overdosage:
Overdose warning: taking more than the recommended dose can cause serious health problems. in case of overdose, get medical help or contact poison control center (1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package Label Principal Display Panel:
Principal display panel goodyâs pm acetaminophen ⢠diphenhydramine citrate pain reliever/ nighttime sleep-aid for pain with sleeplessness 16 powder packs principal display panel goodyâs pm acetaminophen ⢠diphenhydramine citrate pain reliever/ nighttime sleep-aid for pain with sleeplessness 16 powder packs principal display panel goodyâs pm acetaminophen ⢠diphenhydramine citrate pain reliever/ nighttime sleep-aid for pain with sleeplessness 16 powder packs principal display panel goodyâs pm acetaminophen ⢠diphenhydramine citrate pain reliever/ nighttime sleep-aid for pain with sleeplessness 16 powder packs principal display panel goodyâs pm acetaminophen ⢠diphenhydramine citrate pain reliever/ nighttime sleep-aid for pain with sleeplessness 16 powder packs principal display panel goodyâs pm acetaminophen ⢠diphenhydramine citrate pain reliever/ nighttime sleep-aid for pain with sleeplessness 16 powder packs principal display panel goodyâs pm acetaminophen ⢠diphenhydramine citrate pain reliever/ nighttime sleep-aid for pain with sleeplessness 16 powder packs
Further Questions:
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