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  4. Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack

Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack

Acetaminophen, Dextromethorphan Hbr And Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr


Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0067-8161
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack also known as Acetaminophen, Dextromethorphan Hbr And Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack is 0067-8161. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack drug includes . The currest status of Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack drug is Active.

Drug Information:

Drug NDC: 0067-8161
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 Flu Relief Maximum Strength Daytime Nighttime Combo Pack
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Theraflu Flu Relief Maximum Strength
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: Daytime Nighttime Combo Pack
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, Dextromethorphan Hbr And Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr
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: Kit
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:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
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: 27 Jun, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 19 Jun, 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: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:247324
1098496
2604579
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:
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
0067-8161-011 KIT in 1 CARTON (0067-8161-01) * 20 TABLET in 1 BLISTER PACK (0067-8162-01) * 20 TABLET in 1 BLISTER PACK (0067-8163-01)27 Jun, 2022N/ANo
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

Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack


Acetaminophen & more..

Kit
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC: 0067-8161

Purpose:

Purposes pain reliever/fever reducer cough suppressant

Purposes pain reliever/fever reducer antihistamine cough suppressant

Product Elements:

Theraflu flu relief maximum strength daytime nighttime combo pack acetaminophen, dextromethorphan hbr and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr theraflu flu relief max daytime acetaminophen, dextromethorphan hbr acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan crospovidone d&c yellow no. 10 aluminum lake fd&c red no. 40 fd&c yellow no. 6 aluminum oxide magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified starch, corn silicon dioxide sodium starch glycolate type a potato stearic acid talc titanium dioxide dt;1 theraflu flu relief max nighttime acetaminophen, chlorpheniramine maleate, dextromethorphan hbr acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan crospovidone fd&c blue no. 2 aluminum oxide magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide sodium starch glycolate type a potato stearic acid talc titanium dioxide nt;1

Indications and Usage:

Uses • temporarily relieves these symptoms due to a common cold: • headache • minor aches and pains • cough due to minor throat and bronchial irritation • minor sore throat pain • temporarily reduces fever

Uses • temporarily relieves these symptoms due to a common cold: • headache • minor aches and pains • cough due to minor throat and bronchial irritation • minor sore throat pain • runny nose • 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: • 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. • if you are now taking a prescription monoamine oxidase inhibitor (
maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson’s 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 • 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 the blood thinning drug warfarin when using this product do not use more than directed. stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • 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.

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 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. • if you are now taking a prescription monoamine oxidase inhibitor (
maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson’s disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains a mao, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland • 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 the blood thinning drug warfarin • taking sedatives or tranquilizers when using this product • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • 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 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 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. • if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson’s 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 • 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 the blood thinning drug warfarin when using this product do not use more than directed. stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • 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.

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 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. • if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson’s disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains a mao, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland • 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 the blood thinning drug warfarin • taking sedatives or tranquilizers when using this product • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • 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 use more than directed.

When using this product • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating 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 6 hours, while symptoms persist • do not take more than 6 caplets in 24 hours unless directed by a doctor • children under 12 years of age: do not use age dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use

Directions • do not use more than directed • adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist • do not take more than 6 caplets in 24 hours unless directed by a doctor • children under 12 years of age: do not use age dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use

Stop Use:

Stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.

Stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • 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 0067-8161-01 theraflu flu relief max strength* multi-symptom flu relief powerful fever fighting formula that relieves: / body ache / headache / sore throat pain / cough / runny nose (nighttime only) daytime acetaminophen pain reliever / fever reducer dextromethorphan hbr cough suppressant nighttime acetaminophen pain reliever / fever reducer chlorpheniramine maleate antihistamine dextromethorphan hbr cough suppressant 20 daytime caplets 20 nighttime caplets 40 total caplets b-0630-770771-10 theraflu combo 40 ct

Further Questions:

Questions or comments? call 1-855-328-5259

Questions or comments? 1-855-328-5259


Comments/ Reviews:

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