Sed-max

Acetaminophen 500 Mg With Caffeine 65mg

Command Brands, Llc
Human Otc Drug
NDC 69197-029

Sed-max also known as Acetaminophen 500 Mg With Caffeine 65mg is a human otc drug labeled by 'Command Brands, Llc'. National Drug Code (NDC) number for Sed-max is 69197-029. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Sed-max drug includes Acetaminophen - 500 mg/1 Caffeine - 65 mg/1 . The currest status of Sed-max drug is Active.

Drug Information:

Drug NDC:	69197-029
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:	Sed-max
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 500 Mg With Caffeine 65mg
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Command Brands, 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 CAFFEINE - 65 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:	26 Nov, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	16 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, 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:	Command Brands, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	307686 1866143
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.
NUI:	N0000175739 N0000175729 N0000175790 M0023046
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	362O9ITL9D 3G6A5W338E
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 EPC:	Central Nervous System Stimulant [EPC] Methylxanthine [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 PE:	Central Nervous System Stimulation [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Xanthines [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Central Nervous System Stimulant [EPC] Central Nervous System Stimulation [PE] Methylxanthine [EPC] Xanthines [CS]
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
69197-029-20	1 BOTTLE in 1 CARTON (69197-029-20) / 20 TABLET, COATED in 1 BOTTLE	26 Nov, 2014	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.

Other medicines with the same generic name

Sed-max

Acetaminophen 500 Mg With Caffeine 65mg

Tablet, Coated
Command Brands, LLC
NDC: 69197-029

Purpose:

Purpose pain reliever/fever reducer pain reliever aid

Product Elements:

Sed-max acetaminophen 500 mg with caffeine 65mg acetaminophen acetaminophen caffeine caffeine starch, corn croscarmellose crospovidone d&c red no. 27 aluminum lake fd&c red no. 40 fd&c yellow no. 6 hypromelloses microcrystalline cellulose polyethylene glycol, unspecified povidone silicon dioxide stearic acid titanium dioxide az;029

Indications and Usage:

Uses temporary relief of minor aches and pains due to: ? headache ? muscular aches

Warnings:

doctor or pharmacist. 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 ? any new symptoms occur ? painful area is red or swollen ? pain gets worse or lasts more than 10 days ? fever gets worse or lasts more than 3 days these could be signs of a serious skin condition pregnancy/breastfeeding if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children keep out of reach of children. in case of overdose, get medical help or contact a 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 8 caplets in 24 hours, which is the maximum daily amount ? taken with other drugs containing acetaminophen ? adult has 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. caffeine warning: the recommended dose of this product contains about as much caffeine as a cup of coffee. limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. do not use ? if you are allergic to acetaminophen ? with other products containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 ? any new symptoms occur ? painful area is red or swollen ? pain gets worse or lasts more than 10 days ? fever gets worse or lasts more than 3 days these could be signs of a serious skin condition pregnancy/breastfeeding if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children keep out of reach of children. in case of overdose, get medical help or contact a 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.

Dosage and Administration:

Directions ? do not use more than directed ? adults and children 12 years and over: take 2 caplets every 6 hours. do not take more than 8 caplets in 24 hours ? children under 12 years of age: ask a doctor

Stop Use:

Stop use and ask a doctor if ? any new symptoms occur ? painful area is red or swollen ? pain gets worse or lasts more than 10 days ? fever gets worse or lasts more than 3 days these could be signs of a serious skin condition

Package Label Principal Display Panel:

Principal display panel sedmax sedmax

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.