NDC 68163-737 Mucus Relief Cold Flu And Sore Throat Maximum Strength

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

NDC Product Code 68163-737

NDC Code: 68163-737

Proprietary Name: Mucus Relief Cold Flu And Sore Throat Maximum Strength 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 Hbr, Guaifenesin, Phenylephrine Hcl 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.


Code Structure
  • 68163 - Raritan Pharmaceuticals Inc
    • 68163-737 - Mucus Relief Cold Flu And Sore Throat

NDC 68163-737-09

Package Description: 266 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Mucus Relief Cold Flu And Sore Throat Maximum Strength with NDC 68163-737 is a a human over the counter drug product labeled by Raritan Pharmaceuticals Inc. The generic name of Mucus Relief Cold Flu And Sore Throat Maximum Strength is acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Raritan Pharmaceuticals Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.


Mucus Relief Cold Flu And Sore Throat Maximum Strength 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/20mL
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL
  • GUAIFENESIN 400 mg/20mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.

Labeler Name: Raritan Pharmaceuticals Inc
Labeler Code: 68163
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: 02-05-2019 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: 12-31-2020 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.

Mucus Relief Cold Flu And Sore Throat Maximum Strength Product Label Images

Mucus Relief Cold Flu And Sore Throat Maximum Strength 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 20 Ml)

Acetaminophen 650 mg Dextromethorphan HBr 20 mgGuaifenesin 400 mgPhenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer Cough suppressantExpectorantNasal decongestant

Uses

  • •temporarily relieves these common cold and flu symptoms: •nasal congestion •sinus congestion and pressure •cough due to minor throat and bronchial irritation •minor aches and pain •sore throat •headache •temporarily reduces fever •temporarily promotes nasal and/or sinus drainage •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: •more than 6 doses in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks everyday 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

  • •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. •for children under 12 years of age •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 •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema •cough that occurs with too much phlegm (mucus)

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

  • •nervousness, dizziness or sleeplessness occur •pain, nasal congestion 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 persistent headacheThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • •do not take more than directed (see overdose warning) •do not take more than 6 doses in any 24-hour period •measure only with dosing cup provided. Do not use any other dosing device.   •dose as follows or as directed by a doctor •mL = milliliter •adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours •children under 12 years of age: do not use

Other Information

  • •each 20 mL contains: sodium 8 mg •Store at room temperature •Do not refrigerate. •Dosing cup provided

Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Package Label

DRx CHOICE Mucus Relief Cold, Flu & Sore Throat Maximum Strength DRx CHOICE Mucus Relief Cold, Flu & Sore Throat Maximum Strength

* Please review the disclaimer below.

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