Xl-3 Xtreme
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Aptapharma Inc.
Human Otc Drug
NDC 76281-305Xl-3 Xtreme also known as Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate is a human otc drug labeled by 'Aptapharma Inc.'. National Drug Code (NDC) number for Xl-3 Xtreme is 76281-305. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Xl-3 Xtreme drug includes Acetaminophen - 650 mg/30mL Dextromethorphan Hydrobromide - 30 mg/30mL Doxylamine Succinate - 12.5 mg/30mL . The currest status of Xl-3 Xtreme drug is Active.
Drug Information:
| Drug NDC: | 76281-305 |
| 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: | Xl-3 Xtreme |
| 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, Dextromethorphan Hbr, Doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Aptapharma Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE - 30 mg/30mL
DOXYLAMINE SUCCINATE - 12.5 mg/30mL
|
| 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 Jan, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 04 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: | AptaPharma Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1043400
|
| 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: | 0645981000290
0645981000351
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
V9BI9B5YI2
9D2RTI9KYH
|
| 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: | Antihistamine [EPC]
Histamine Receptor Antagonists [MoA]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
|
| 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 |
|---|
| 76281-305-28 | 354 mL in 1 BOTTLE (76281-305-28) | 01 Jan, 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:
Purpose pain reliever/fever reducer cough suppressant antihistamine
Product Elements:
Xl-3 xtreme acetaminophen, dextromethorphan hbr, doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine citric acid monohydrate fd&c blue no. 1 fd&c red no. 40 glycerin polyethylene glycol, unspecified propylene glycol water saccharin sodium sodium benzoate sodium citrate sucrose xl-3 xtreme acetaminophen, dextromethorphan hbr, doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine citric acid monohydrate fd&c blue no. 1 fd&c red no. 40 glycerin polyethylene glycol, unspecified propylene glycol water saccharin sodium sodium benzoate sodium citrate sucrose
Indications and Usage:
Use temporarily relieves cold/flu symptoms: ⢠sore throat headache ⢠minor aches and pain ⢠fever ⢠runny nose and sneezing ⢠cough due to minor throat and bronchial irritation
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: ⢠skin reddening ⢠blisters ⢠rash. if a skin reaction occurs, stop use and seek medical help right away. sore throat warning : if sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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: ⢠skin reddening ⢠blisters ⢠rash. if a skin reaction occurs, stop use and seek medical help right away. sore throat warning : if sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
When Using:
When using this product ⢠do not use more than directed ⢠avoid alcoholic drinks ⢠excitability may occur, especially in children ⢠marked drowsiness may occur ⢠be careful when driving a motor vehicle or operating machinery ⢠alcohol, sedatives and tranquilizers may increase drowsiness.
Dosage and Administration:
Directions ⢠take only as recommended-see overdose warning ⢠use dose cup or tablespoon (tbsp) ⢠do not exceed 4 doses per 24 hours ⢠if taking night time at night and day time during the day, limit total to 4 doses per 24 hours. adults & children 12 years and over 30 ml (2 tbsp) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use
Stop Use:
Stop use and ask a doctor if ⢠redness or swelling is present ⢠symptoms do not get better within 7 days or are accompanied by a fever ⢠fever gets worse or lasts more than 3 days ⢠new symptoms occur ⢠cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. these could be signs of a serious condition.
Overdosage:
Overdose warning: taking more than the recommended dose (overdose) may cause serious health problems including liver damage. in case of accidental overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Package Label Principal Display Panel:
Xl-3 xtreme night time cold and cough xl-3* xtreme cherry flavor night time multi-symptom cold/flu relief cold and cough ⢠acetaminophen - pain reliever/fever reducer ⢠dextromethorphan hbr - cough suppressant ⢠doxylamine succinate - antihistamine fast relief of: sneezing & runny nose fever aches & pains cough sore throat 12 fl oz (354 ml) xl-3* xtreme cherry flavor night time multi-symptom cold/flu relief cold and cough ⢠acetaminophen - pain reliever/fever reducer ⢠dextromethorphan hbr - cough suppressant ⢠doxylamine succinate - antihistamine fast relief of: sneezing & runny nose fever aches & pains cough sore throat 12 fl oz (354 ml) xl-3* xtreme cold and cough do not use if printed shrink band is missing or broken failure to follow these warnings could result in serious consequences drug facts active ingredients purpose (in each 30 ml dose cup) acetaminophen 650 mg ........................ pain reliever/fever reducer dextromethorphan hbr 30 mg ..........................cough suppressant doxylamine succinate 12.5 mg ...................................antihistamine uses temporarily relieves cold/flu symptoms: ⢠sore throat headache ⢠minor aches and pain ⢠fever ⢠runny nose and sneezing ⢠cough due to minor throat and bronchial irritation â drug facts continued on back â distributed by: midway importing, inc. 1807 brittmoore road, houston, tx 77043 1-800-531-3873 made in usa peel lr-060 rev 03 back ⺠xl-3* xtreme cold and cough drug facts (continued) 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: ⢠skin reddening ⢠blisters ⢠rash. if a skin reaction occurs, stop use and seek medical help right away. sore throat warning : if sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use ⢠with any other products containing acetaminophen (prescription or nonprescription). lf you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist ⢠for more than10 days for pain unless directed by a doctor ⢠for more than 3 days for fever unless directed by a doctor ⢠if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinsonâs disease), or for 2 weeks after stopping the maoi drugs. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ⢠to make a child sleepy. ask a doctor before use if you have ⢠a sodium restricted diet ⢠liver disease ⢠glaucoma ⢠cough that occurs with too much phlegm (mucus) ⢠a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ⢠trouble urinating due to enlarged prostate gland. ask a doctor or pharmacist before use ⢠if you are taking sedatives or tranquilizers ⢠if you are taking the blood thinning drug warfarin. ⺠drug facts (continued) when using this product ⢠do not use more than directed ⢠avoid alcoholic drinks ⢠excitability may occur, especially in children ⢠marked drowsiness may occur ⢠be careful when driving a motor vehicle or operating machinery ⢠alcohol, sedatives and tranquilizers may increase drowsiness. stop use and ask a doctor if ⢠redness or swelling is present ⢠symptoms do not get better within 7 days or are accompanied by a fever ⢠fever gets worse or lasts more than 3 days ⢠new symptoms occur ⢠cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. 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 (overdose) may cause serious health problems including liver damage. in case of accidental overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. directions ⢠take only as recommended-see overdose warning ⢠use dose cup or tablespoon (tbsp) ⢠do not exceed 4 doses per 24 hours ⢠if taking night time at night and day time during the day, limit total to 4 doses per 24 hours. adults & children 12 years and over 30 ml (2 tbsp) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use other information ⢠each 30 ml dose cup contains: sodium 45 mg ⢠store at 20°-25°c (68°-77° f). inactive ingredients citric acid, fd & c blue no.1, fd & c red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose. questions or comments? call weekdays from 9:30 am to 4:30 pm est 1-877-798-5944 xl-3* xtreme cherry flavor night time multi-symptom cold/flu relief cold and cough ⢠acetaminophen - pain reliever/fever reducer ⢠dextromethorphan hbr - cough suppressant ⢠doxylamine succinate - antihistamine fast relief of: sneezing & runny nose fever aches & pains cough sore throat 6 fl oz (177 ml) xl-3 night time xtreme xl-3 xtreme 2 xl-3 nightime 6_oz
Further Questions:
Questions or comments? call weekdays from 9:30 am to 4:30 pm est 1-877-798-5944