NDC 55629-016 Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate

NDC Product Code 55629-016

NDC CODE: 55629-016

Proprietary Name: Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate 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, Phenylephrine Hcl, Doxylamine Succinate 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

  • 55629 - One2zee Limited Liability Company
    • 55629-016 - Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate

NDC 55629-016-01

Package Description: 48 POUCH in 1 CARTON > 300 CAPSULE, LIQUID FILLED in 1 POUCH (55629-016-02)

NDC Product Information

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate with NDC 55629-016 is a a human over the counter drug product labeled by One2zee Limited Liability Company. The generic name of Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate is acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: One2zee Limited Liability Company

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate 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 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
  • DOXYLAMINE SUCCINATE 6.25 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.

  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE K30 (UNII: U725QWY32X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • GELATIN (UNII: 2G86QN327L)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)

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: One2zee Limited Liability Company
Labeler Code: 55629
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: 03-02-2021 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate Product Label Images

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate 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 Capsule)

Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine Hydrochloride 5 mgDoxylamine Succinate 6.25 mg

Purpose

Pain reliever/ fever reducerCough suppressantAntihistamineNasal decongestant

Uses

  • Temporarily relieves common cold/flu symptoms:    ο nasal congestion    ο sinus congestion & pressure    ο cough due to minor throat & bronchial irritation    ο minor aches & pains    ο headache    ο fever    ο sore throatreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainagehelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warning

  • Liver warningThis product contains acetaminophen. Severe liver damage may occur if you takemore than 10 softgels in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productSore throat warningIf 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 to sedate children.

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.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.if you have ever had an allergic reaction to this product or any of its ingredientsin children under 12 years of age

Ask A Doctor Before Use If You Have

  • Liver diseaseheart diseasehigh blood pressurethyroid diseasediabetesglaucomacough with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysema

When Using This Product

  • Do not exceed recommended dosagemay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Stop Use And Ask A Doctor If

  • Pain, cough, or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.nervousness, dizziness, or sleeplessness occurs

Overdose Warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Direction

  • Take only as directed - see Overdose warningdo not exceed 4 doses per 24 hoursadults & children 12 years of age and over2 softgels with water every 4 hoursChildren under 12 years of ageask a doctorWhen using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Other Information:

  • Store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

Polyethylene glycol 400, propylene glycol, povidone k30, sodium hydroxide, FD&C blue #1, D&C yellow #10, titanium dioxide, gelatin, glycerin, sorbitol, water

* Please review the disclaimer below.