NDC 70000-0156 Leader Multi Symptom Flu And Severe Cold
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl Powder, For Solution Oral

Product Information

Leader Multi Symptom Flu And Severe Cold is a human over the counter drug product labeled by Cardinal Health 110, Llc. Dba Leader. The generic name of Leader Multi Symptom Flu And Severe Cold is acetaminophen, dextromethorphan hbr, phenylephrine hcl. The product's dosage form is powder, for solution and is administered via oral form.

Product Code70000-0156
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.
Leader Multi Symptom Flu And Severe Cold
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
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 FormPowder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Cardinal Health 110, Llc. Dba Leader
Labeler Code70000
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.
01-31-2017
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.
12-31-2023
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 Leader Multi Symptom Flu And Severe Cold?


Product Characteristics

Flavor(s)HONEY (C73394 - LEMON AND GREEN TEA)

Product Packages

NDC 70000-0156-1

Package Description: 6 POWDER, FOR SOLUTION in 1 CARTON

Price per Unit: $0.49833 per EA

Product Details

What are Leader Multi Symptom Flu And Severe Cold Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 500 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

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

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)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ASPARTAME (UNII: Z0H242BBR1)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Pharmacologic Class(es)

* Please review the disclaimer below.

Leader Multi Symptom Flu And Severe Cold Labeling and Warnings

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.

Table of Contents



Active Ingredients (In Each Packet)



Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg


Purposes



Pain reliever/fever reducer

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

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 have ever had an allergic reaction to this product or any of its ingredients
  • •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
  • •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
  • •a sodium-restricted diet

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 serious condition.

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 (see overdose warning)
  • •take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.
  • Age

    Dose

    adults and children 12 years of age and over

    one packet

    children under 12 years of age

    do 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 and sodium 25 mg
  • •phenylketonurics: contains phenylalanine 22 mg per packet
  • •store at 20-25°C (68-77°F). Protect product from heat and moisture.

Inactive Ingredients



acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Daytime

Multi-Symptom Flu & Severe Cold

Acetaminophen

Dextromethorphan HBr

Phenylephrine HCl

Pain Reliever/Fever Reducer

Cough Suppressant

Nasal Suppressant

Green Tea & Honey Lemon Flavors

Relieves:

Nasal Congestion, Cough, Body Ache, Sore Throat Pain, Headache, Fever

COMPARE TO THERAFLU®

MULTI-SYMPTOM SEVERE COLD

active ingredients

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6 PACKETS


* Please review the disclaimer below.