Theraflu Expressmax Nighttime Severe Cold And Cough
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0067-8137Theraflu Expressmax Nighttime Severe Cold And Cough also known as Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Theraflu Expressmax Nighttime Severe Cold And Cough is 0067-8137. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Theraflu Expressmax Nighttime Severe Cold And Cough drug includes Acetaminophen - 325 mg/1 Diphenhydramine Hydrochloride - 12.5 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Theraflu Expressmax Nighttime Severe Cold And Cough drug is Active.
Drug Information:
| Drug NDC: | 0067-8137 |
| 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: | Theraflu Expressmax Nighttime Severe Cold And Cough |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Theraflu Expressmax |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Nighttime Severe Cold and Cough |
| 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, Diphenhydramine Hcl, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| 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 - 325 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE - 12.5 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 5 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 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: | 05 Jul, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 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: | 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: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1233575
|
| 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. |
| UNII: | 362O9ITL9D
TC2D6JAD40
04JA59TNSJ
|
| 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: | Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
alpha-1 Adrenergic Agonist [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 |
|---|
| 0067-8137-10 | 1 BLISTER PACK in 1 CARTON (0067-8137-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 08 Jun, 2017 | N/A | No |
| 0067-8137-20 | 2 BLISTER PACK in 1 CARTON (0067-8137-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 05 Jul, 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 pain reliever/fever reducer antihistamine/cough suppressant nasal decongestant
Product Elements:
Theraflu expressmax nighttime severe cold and cough acetaminophen, diphenhydramine hcl, phenylephrine hcl acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine benzoic acid croscarmellose sodium alcohol fd&c blue no. 2 aluminum oxide ferrosoferric oxide hypromellose, unspecified magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol, unspecified polysorbate 60 polysorbate 80 povidone, unspecified starch, corn propylene glycol silicon dioxide stearic acid sucralose titanium dioxide caplet 1143n
Indications and Usage:
Uses ⢠temporarily relieves these symptoms due to a cold: o minor aches and pains o minor sore throat pain o headache o nasal and sinus congestion o runny nose o sneezing o itchy nose or throat o itchy, watery eyes due to hay fever o cough due to minor throat and bronchial irriation ⢠temporarily reduces fever
Warnings:
Warnings liver warning: this product ocontains acetaminophen. severe lever 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 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. do not use ⢠in a child under 12 years of age 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 product containing diphenhydramine, even one used on the skin
Read more...¢ 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 drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have ⢠liver disease ⢠heart disease ⢠high blood pressure ⢠thyroid disease ⢠diabetes ⢠glaucoma ⢠trouble urinating due to an enlarged prostate gland ⢠a breathing problem such as emphysema or chronic bronchitis ⢠cough that occurs with too much phlegm (mucus) ⢠cough that lasts or is chronic such as occurs with smoking, asthma or emphysema ask a doctor or pharmacist before use if you are ⢠taking sedatives or tranquilizers ⢠taking the blood thinning drug warfarin when using this product ⢠do not exceed recommended dosage ⢠avoid alcoholic drinks ⢠marked drowsiness may occur ⢠alcohol, sedatives and tranquilizers may increase drowsiness ⢠be careful when driving a motor vehicle or operation machinery ⢠excitability may occur, especially in children stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occurs ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠pain, cough or nasal congestion gets worse or lasts more than 7 days ⢠cough comes back or occurs with 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. 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.
Do Not Use:
Warnings liver warning: this product ocontains acetaminophen. severe lever 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 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. do not use ⢠in a child under 12 years of age 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 product containing diphenhydramine, even one used on the skin ⢠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 drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have ⢠liver disease ⢠heart disease ⢠high blood pressure ⢠thyroid disease ⢠diabetes ⢠glaucoma ⢠trouble urinating due to an enlarged prostate gland ⢠a breathing problem such as emphysema or chronic bronchitis ⢠cough that occurs with too much phlegm (mucus) ⢠cough that lasts or is chronic such as occurs with smoking, asthma or emphysema ask a doctor or pharmacist before use if you are ⢠taking sedatives or tranquilizers ⢠taking the blood thinning drug warfarin when using this product ⢠do not exceed recommended dosage ⢠avoid alcoholic drinks ⢠marked drowsiness may occur ⢠alcohol, sedatives and tranquilizers may increase drowsiness ⢠be careful when driving a motor vehicle or operation machinery ⢠excitability may occur, especially in children stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occurs ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠pain, cough or nasal congestion gets worse or lasts more than 7 days ⢠cough comes back or occurs with 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. 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.
When Using:
When using this product ⢠do not exceed recommended dosage ⢠avoid alcoholic drinks ⢠marked drowsiness may occur ⢠alcohol, sedatives and tranquilizers may increase drowsiness ⢠be careful when driving a motor vehicle or operation machinery ⢠excitability may occur, especially in children
Dosage and Administration:
Directions ⢠do not use more than directed ⢠adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist. do not take more than 10 caplets in 24 hours unless directed by a doctor ⢠children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occurs ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠pain, cough or nasal congestion gets worse or lasts more than 7 days ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel ndc 0067-8137-20 theraflu ® express max⢠nighttime severe cold & cough new! warming relief⢠formula acetaminophen â pain reliever/fever reducer diphenhydramine hcl â antihistamine/cough suppressant pehnylephrine hcl â nasal decongestant ⢠nasal congestion ⢠sore throat ⢠fever ⢠body ache ⢠runny nose ⢠headache ⢠cough 20 coated caplets *maximum strength per 4 hour dose. tamper evident feature: theraflu ® expressmax ⢠caplets are sealed in blister packets. use only if the individual seal is unbroken. distributed by: gsk consumer healthcare, warren, nj 07059 trademarks are owned by or licensed to the gsk group of companies. ©2016 gsk group of companies or its licensor. all rights reserved. www.theraflu.com 46171251 theraflu expressmax nighttime severe cold and cough caplet carton
Further Questions:
Questions or comments? call 1-800-452-0051