NDC 0067-6094 Theraflu Powerpods Daytime Severe Cold

Acetaminophen, Dextromethorphan, Phenylephrine

NDC Product Code 0067-6094

NDC CODE: 0067-6094

Proprietary Name: Theraflu Powerpods Daytime Severe Cold 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.

Non-Proprietary Name: Acetaminophen, Dextromethorphan, Phenylephrine 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.

NDC Code Structure

NDC 0067-6094-01

Package Description: 8 POUCH in 1 CARTON > 1 POWDER, FOR SOLUTION in 1 POUCH (0067-6094-02)

NDC 0067-6094-03

Package Description: 1 POUCH in 1 CARTON > 1 POWDER, FOR SOLUTION in 1 POUCH

NDC Product Information

Theraflu Powerpods Daytime Severe Cold with NDC 0067-6094 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Theraflu Powerpods Daytime Severe Cold is acetaminophen, dextromethorphan, phenylephrine. The product's dosage form is powder, for solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1659967.

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

Product Type: Human Otc Drug 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.

Theraflu Powerpods Daytime Severe Cold Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0067
FDA Application Number: part341 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 07-28-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

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Information for Patients


Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Theraflu Powerpods Daytime Severe Cold Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each Pod)

Acetaminophen 650 mgDextromethorphan HBr 20 mgPhenylephrine HCl 10 mg


Pain reliever/Fever reducerCough suppressantNasal decongestant


  • •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


  • 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 productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf 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 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

Ask A Doctor Or Pharmacist Before Use If You Are

  • •taking the blood thinning drug warfarin

When Using This Product

  • •do not exceed recommended dosage

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 more than directed •take every 4 hours, while symptoms persist. Do not take more than 5 pods in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years of age and overone podchildren under 12 years of agedo not use •do not remove the foil seal as the pod will not work properly and could result in hot water burns •place pod in compatible brewer •use a minimum of 8 oz. of water •when finished, the pod will be hot and may drip. Tilt the pod during removal to avoid dripping. •remove used pod and flush brewer after use with a minimum of 8 oz. of water •sip while hot. Consume entire drink within 10-15 minutes.

Other Information

  • •each pod contains: potassium 10 mg, sodium 20 mg •phenylketonurics: contains phenylalanine 14 mg per pod •do not open pouch until time of use •store at controlled room temperature 20o-25oC (68o-77oF). Protect product from heat and moisture.

Inactive Ingredients

Acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Principal Display

  • NDC 0067-6094-01NEWTHERAFLUPOWERPODSDAYTIMESEVERE COLDACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCERDEXTROMETHORPHAN HBr – COUGH SUPPRESSANTPHENYLEPHRINE HCl – NASAL DECONGESTANT •Nasal Congestion •Sore Throat Pain •Cough •Headache •Body Ache •FeverBERRY INFUSED WITH MENTHOL & GREEN TEA FLAVORS8 PODSFOR USE ONLY WITH COMPATIBLE SINGLE SERVE BREWING MACHINES INCLUDING KEURIG AND MR. COFFEE**This product is not affiliated with Keurig Incorporated or Mr. Coffee.READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.KEEP CARTON FOR REFERENCE. DO NOT DISCARD.TAMPER EVIDENT POUCH. PRODUCT IS PACKAGED IN INDIVIDUAL SEALED POUCHES. DO NOT USE IF POUCH IS TORN OR BROKEN. DO NOT OPEN POUCH UNTIL TIME OF USE. PARENTS:Learn about teen medicine abusewww.StopMedicineAbuse.orgPRESSPress the 8 oz. setting on your machine to brew.SIPSip while hot. Consume entire drink within 10-15 minutes. Remove used pod and flush brewer after usewith a minimum of 8 oz. of water.CAUTION: PRODUCT LIQUID AND POD WILL BE HOT.RELIEFPrepare to experience powerful cold & flu multi-symptom relief.1-855-328-5259Distributed by:GSK Consumer Healthcare, Warren, NJ 07059©2018 GSK group of companies or its licensor.Trademarks are owned by or licensed to the GSK group of companies. 13019

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