Valumeds Aspirin Free Headache Relief Pm
Acetaminophen And Diphenhydramine Citrate
Spirit Pharmaceuticals Llc
Human Otc Drug
NDC 68210-2000Valumeds Aspirin Free Headache Relief Pm also known as Acetaminophen And Diphenhydramine Citrate is a human otc drug labeled by 'Spirit Pharmaceuticals Llc'. National Drug Code (NDC) number for Valumeds Aspirin Free Headache Relief Pm is 68210-2000. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Valumeds Aspirin Free Headache Relief Pm drug includes Acetaminophen - 500 mg/1 Diphenhydramine Citrate - 38 mg/1 . The currest status of Valumeds Aspirin Free Headache Relief Pm drug is Active.
Drug Information:
| Drug NDC: | 68210-2000 |
| 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: | Valumeds Aspirin Free Headache Relief 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: | Spirit Pharmaceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, 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 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 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: | 10 Apr, 2018 |
| 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: | SPIRIT PHARMACEUTICALS LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1099872
|
| 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: | 0040232605277
|
| 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 |
|---|
| 68210-2000-2 | 1 BOTTLE in 1 CARTON (68210-2000-2) / 20 TABLET, COATED in 1 BOTTLE | 10 Apr, 2018 | 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:
Active ingredients (in each caplet) purpose acetaminophen 500 mg pain reliever diphenhydramine citrate 38 mg nighttime sleep-aid
Product Elements:
Valumeds aspirin free headache relief pm acetaminophen and diphenhydramine citrate silicon dioxide fd&c blue no. 1 fd&c blue no. 2 hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified povidone k30 starch, corn stearic acid titanium dioxide acetaminophen acetaminophen diphenhydramine citrate diphenhydramine s26
Indications and Usage:
Uses for the 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 2 caplets 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 or general allergic reaction occurs, stop use and seek medical help right away. do not use if you are allergic to acetaminophen 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 in children under 12 years of age 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 befor
Read more...e use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product avoid alcoholic drinks drowsiness may occur be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if any new symptoms occur sleeplessness lasts continuously for more than 2 weeks. insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days painful area is red or swollen fever gets worse or lasts more than 3 days 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. 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 2 caplets 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 or general allergic reaction occurs, stop use and seek medical help right away. do not use if you are allergic to acetaminophen 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 in children under 12 years of age 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 taking sedatives or tranquilizers when using this product avoid alcoholic drinks drowsiness may occur be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if any new symptoms occur sleeplessness lasts continuously for more than 2 weeks. insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days painful area is red or swollen fever gets worse or lasts more than 3 days 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. 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 avoid alcoholic drinks drowsiness may occur be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not use more than directed do not use in children under 12 years of age adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
Stop Use:
Stop use and ask a doctor if any new symptoms occur sleeplessness lasts continuously for more than 2 weeks. insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days painful area is red or swollen fever gets worse or lasts more than 3 days
Package Label Principal Display Panel:
Principal display panel - 20 count bottle carton valumeds⢠compare to the active ingredients in excedrin® pm* aspirin-free headache relief pm acetaminophen 500 mg, diphenhydramine citrate 38 mg pain reliever nighttime sleep-aid 20 caplets image description
Further Questions:
Questions or comments? 1-888-333-9792