Backaid Max
Acetaminophen, Pamabrom
Alva-amco Pharmacal Companies, Inc.
Human Otc Drug
NDC 52389-153Backaid Max also known as Acetaminophen, Pamabrom is a human otc drug labeled by 'Alva-amco Pharmacal Companies, Inc.'. National Drug Code (NDC) number for Backaid Max is 52389-153. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Backaid Max drug includes Acetaminophen - 500 mg/1 Pamabrom - 25 mg/1 . The currest status of Backaid Max drug is Active.
Drug Information:
| Drug NDC: | 52389-153 |
| 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: | Backaid Max |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Backaid |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Max |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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, Pamabrom |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alva-amco Pharmacal Companies, Inc. |
| 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
PAMABROM - 25 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: | 01 Feb, 1992 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | Alva-Amco Pharmacal Companies, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198449
1356080
|
| 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: | 0072959530280
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
UA8U0KJM72
|
| 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 |
|---|
| 52389-153-14 | 1 BLISTER PACK in 1 CARTON (52389-153-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK (52389-153-01) | 01 Jun, 2011 | N/A | No |
| 52389-153-28 | 2 BLISTER PACK in 1 CARTON (52389-153-28) / 14 TABLET, FILM COATED in 1 BLISTER PACK (52389-153-01) | 01 Mar, 2011 | N/A | No |
| 52389-153-35 | 5 BLISTER PACK in 1 CARTON (52389-153-35) / 7 TABLET, FILM COATED in 1 BLISTER PACK | 01 Jun, 2011 | N/A | No |
| 52389-153-38 | 1 BOTTLE, PLASTIC in 1 CARTON (52389-153-38) / 38 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52389-153-03) | 01 Sep, 2010 | N/A | No |
| 52389-153-46 | 1 BOTTLE in 1 CARTON (52389-153-46) / 46 TABLET, FILM COATED in 1 BOTTLE | 29 Apr, 2016 | 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 analgesic (pain reliever) diuretic
Product Elements:
Backaid max acetaminophen, pamabrom calcium sulfate dihydrate starch, corn croscarmellose sodium d&c yellow no. 10 fd&c yellow no. 6 hypromelloses magnesium oxide talc magnesium stearate cellulose, microcrystalline light mineral oil polyethylene glycol 400 potassium gluconate sodium lauryl sulfate sodium starch glycolate type a potato sorbitol stearic acid titanium dioxide povidone acetaminophen acetaminophen pamabrom bromotheophylline goldenrod alva
Indications and Usage:
Uses for the temporary relief of: minor aches, pains and related discomforts due to muscle strain, spasms or overexertion including those affecting the back, legs and joints pressure-caused discomforts due to periodic excess water retention
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 6 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 reaction occurs, stop use and seek medical help right away.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 6 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 reaction occurs, stop use and seek medical help right away.
Dosage and Administration:
Directions read all package directions and warnings before use. use only as directed. adults: two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor. do not exceed recommended dosage. for use by normally healthy adults only. persons under 18 years of age should use only as directed by a doctor.
Stop Use:
Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse
Information for Patients:
Other information magnesium content: 5 mg/caplet **contents sealed: each backaid max goldenÂ-colored, oval shaped caplet bears the identifying mark "alva" and is sealed in a clear plastic blister with a paper/foil backing. do not use if seal appears broken or if product contents do not match product description. you may report serious side effects to the phone number provided under questions? below.
Spl Patient Package Insert:
Package insert aspirin free backache relief backaid max 1000 mg strong per 2 caplet dose maximum strength 6 hour formula active ingredients: each caplet contains: acetaminophen 500 mg (analgesic/pain reliever) and pamabrom 25 mg (diuretic). uses: for the temporary relief of: ⢠minor aches, pains and related discomforts due to muscle strain, spasms or overexertion including those affecting the back, legs and joints. ⢠pressure-caused discomforts due to periodic excess water retention. warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 6 caplets in 24 hours, which is the maximum dally 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. d
Read more...o not use ⢠with any other drug containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠for more than 10 days for pain unless directed by a doctor ⢠for more than 3 days for fever unless directed by a doctor. 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 symptoms do not improve new symptoms occur pain or fever persists or gets worse if pregnant or breast feeding, ask a health professional before use. keep out of reach of children. in case of 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. directions: read all package directions and warnings before use. use only as directed. adults: two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor. do not exceed recommended dosage. for use by normally healthy adults only. persons under 18 years of age should use only as directed by a doctor. other information: magnesium content: 5 mg/caplet **contents sealed: each backaid max golden-Âcolored, oval shaped caplet bears the identifying mark "alva" and is sealed in a clear plastic blister with a paper/foil backing. do not use if seal appears broken or if product contents do not match product description. ⢠you may report serious side effects to the phone number provided under questions? below. inactive ingredients calcium sulfate, croscarmellose sodium, d&c yellow #10 lake, fd&c yellow #6 lake, hypromellose, magnesium oxide, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, potassium gluconate, sodium lauryl sulfate, sodium starch glycolate, sorbitol, starch, stearic acid, talc and titanium dioxide. questions? 1-800-792-2582
Package Label Principal Display Panel:
Backaidpdp
Further Questions:
Questions? 1-800-792-2582.