Extra Strength Pain Reliever
Acetaminophen
Walgreen Company
Human Otc Drug
NDC 0363-0531Extra Strength Pain Reliever also known as Acetaminophen is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Extra Strength Pain Reliever is 0363-0531. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Extra Strength Pain Reliever drug includes Acetaminophen - 500 mg/1 . The currest status of Extra Strength Pain Reliever drug is Active.
Drug Information:
| Drug NDC: | 0363-0531 |
| 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: | Extra Strength Pain Reliever |
| 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: | Walgreen Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film 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
|
| 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: | 11 Dec, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| 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, 2024 |
| 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: | Walgreen Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198440
|
| 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: | 0311917154312
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 0363-0531-12 | 1 BOTTLE, PLASTIC in 1 CARTON (0363-0531-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 11 Dec, 2005 | N/A | No |
| 0363-0531-15 | 1 BOTTLE, PLASTIC in 1 CARTON (0363-0531-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 11 Dec, 2005 | 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
Product Elements:
Extra strength pain reliever acetaminophen acetaminophen acetaminophen starch, corn d&c red no. 27 aluminum lake d&c yellow no. 10 aluminum lake fd&c blue no. 1 aluminum lake polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified stearic acid sucralose talc titanium dioxide sodium starch glycolate type a potato 44;531
Indications and Usage:
Uses temporarily relieves minor aches and pains due to: headache toothache muscular aches backache the common cold minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever
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: blisters rash skin reddening 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 you have liver disease. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling i
Read more...s 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. in case of accidental overdose, get medical help or contact a poison control center right away. prompt 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: blisters rash skin reddening 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 you have liver disease. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts 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. in case of accidental overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage and Administration:
Directions do not take more than directed adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel walgreens compare to the active ingredient in extra strength tylenol ® ndc 0363-0531-12 pain reliever acetaminophen 500 mg / pain reliever / fever reducer extra strength 100 coated tablets actual size tamper evident: do not use if imprinted safety seal under cap is broken or missing our pharmacists recommend the walgreens brand. we invite you to compare to national brands. this product is not manufactured or distributed by johnson & johnson corporation, owner of the registered trademark extra strength tylenol ® . 50844 org122053112 distributed by: walgreen co. 200 wilmot rd., deerfield, il 60015 100% satisfaction guaranteed walgreens.com ©2021 walgreen co. item 243692 walgreens b-2201-531c-12-hr org1220 walgreens b-2201-531c-12-hr org1220
Further Questions:
Questions or comments? 1-800-426-9391