NDC 0067-6804 Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hcl Kit

Product Information

What is NDC 0067-6804?

The NDC code 0067-6804 is assigned by the FDA to the product Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime is acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl. The product's dosage form is kit and is administered via form. The product is distributed in a single package with assigned NDC code 0067-6804-02 1 kit in 1 package, combination * 6 packet in 1 carton (0067-6802-02) / 237 ml in 1 packet * 6 packet in 1 carton (0067-6803-02) / 237 ml in 1 packet. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0067-6804
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hcl
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormKit - A packaged collection of related material.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0067
FDA Application Number What is the FDA Application Number?
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.
part341
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-20-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime?


Product Characteristics

Flavor(s)HONEY (C73394 - HONEY LEMON FLAVOR)

Product Packages

NDC Code 0067-6804-02

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 6 PACKET in 1 CARTON (0067-6802-02) / 237 mL in 1 PACKET * 6 PACKET in 1 CARTON (0067-6803-02) / 237 mL in 1 PACKET

Product Details

Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution
  • RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
  • RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution
  • RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
  • RxCUI: 1189316 - APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution

Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients (In Each Packet)



Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg


Purposes



Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Nasal decongestant


Uses



  • •temporarily relieves these symptoms due to a cold:
    • •minor aches and pains
    • •minor sore throat pain
    • •headache
    • •nasal and sinus congestion
    • •cough due to minor throat and bronchial irritation
    • •temporarily reduces fever
      • •temporarily relieves these symptoms due to a cold:
        • •minor aches and pains
        • •minor sore throat pain
        • •headache
        • •nasal and sinus congestion
        • •runny nose
        • •sneezing
        • •itchy nose or throat
        • •itchy, watery eyes due to hay fever
        • •cough due to minor throat and bronchial irritation
        • •temporarily reduces fever

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.

      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.
    • •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 other 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 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
  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •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
    • •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 the blood thinning drug warfarin
    • •taking sedatives or tranquilizers
    • •taking the blood thinning drug warfarin

When Using This Product



  • do not exceed recommended dosage
    • 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 operating 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.
    • •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.

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.

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



  • do not use more than directed
  • •take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.
  • AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use
     
     
     
     
     
     
    • •dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    • •if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
      • do not use more than directed
      • •take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
      • AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use
         
         
         
         
         
         
        • •dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
        • •if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other Information



  • each packet contains: potassium 10 mg, sodium 19 mg
  • phenylketonurics: contains phenylalanine 20 mg per packet
  • •store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
    • each packet contains: potassium 10 mg, sodium 23 mg
    • phenylketonurics: contains phenylalanine 13 mg per packet
    • •store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Inactive Ingredients



acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate


Questions Or Comments?



call 1-855-328-5259

call 1-855-328-5259


Additional Information



DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER-EVIDENT INNER UNIT

DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.

1-855-328-5259

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2022 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT TAKE A DOSE OF THE SEVERE COLD RELIEF NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF SEVERE COLD RELIEF DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.


Principal Display Panel



NDC 0067-6804-02

THERAFLU

SEVERE COLD RELIEF

COMBO PACK

6 x DAYTIME

Acetaminophen Pain Reliever/Fever Reducer

Dextromethorphan HBr Cough Suppressant

Phenylephrine HCl Nasal Decongestant

6 x NIGHTTIME

Acetaminophen Pain Reliever/Fever Reducer

Diphenhydramine HCl Antihistamine/Cough Suppressant

Phenylephrine HCl Nasal Decongestant

Hot liquid therapy that relieves:

Nasal and sinus congestion

Sore throat / Cough / Fever

Runny nose (Nighttime only)

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon

CM20326

THERAFLU

SEVERE COLD RELIEF

DAYTIME FORMULA

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Hot liquid therapy that relieves:

Nasal and sinus congestion

Cough

Sore throat pain

Headache

Fever

Honey Lemon

6 PACKETS

62000000075408 – Front Carton

THERAFLU

SEVERE COLD RELIEF

NIGHTTIME

HELPS YOU REST

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Hot liquid therapy that relieves:

Nasal and sinus congestion

Cough

Sore throat pain

Headache

Runny nose

Fever

Honey Lemon

6 PACKETS

62000000075405 – Front Carton


* Please review the disclaimer below.