NDC 0067-7916 Theraflu Flu And Sore Throat

Acetaminophen, Pheniramine Maleate, Phenylephrine Hcl

NDC Product Code 0067-7916

NDC 0067-7916-06

Package Description: 6 PACKET in 1 CARTON > 1 POWDER, FOR SOLUTION in 1 PACKET (0067-7916-01)

NDC Product Information

Theraflu Flu And Sore Throat with NDC 0067-7916 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Theraflu Flu And Sore Throat is acetaminophen, pheniramine maleate, phenylephrine hcl. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

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 Flu And Sore Throat 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.

  • ACETAMINOPHEN 650 mg/1
  • PHENIRAMINE MALEATE 20 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1

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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)
  • TRIACETIN (UNII: XHX3C3X673)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

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

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: 05-13-2005 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Theraflu Flu And Sore Throat Product Label Images

Theraflu Flu And Sore Throat 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 Ingredient (In Each Packet)

Acetaminophen, 650 mgPheniramine maleate, 20 mgPhenylephrine hydrochloride, 10 mg

Purpose

Pain reliever / fever reducerAntihistamineNasal decongestant

Uses

  • •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 •temporarily reduces fever

Warnings

  • Allergy 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.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 productSore 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 a 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 •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 •a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

  • •taking sedatives or tranquilizers •the blood thinning drug warfarin

When Using This Product

  • •do not exceed recommended dosage •avoid alcoholic drinks •may cause drowsiness •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 •pain or nasal congestion gets worse or lasts more than 7 days •fever gets worse or lasts more than 3 days •new symptoms occur •redness or swelling is present. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health care 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.

Directions

  • •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 doctorAgeDoseadults 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 51 mg •store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Inactive Ingredients

Acesulfame potassium, apple cinnamon flavors, citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, lecithin, maltodextrin, medium chain triglycerides, silicon dioxide, sodium chloride, sodium citrate, sucrose, triacetin, tribasic calcium phosphate

* Please review the disclaimer below.