NDC 51013-415 Cold Flu And Sore Throat Relief

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 51013-415

NDC CODE: 51013-415

Proprietary Name: Cold Flu And Sore Throat Relief 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 Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride 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

  • 51013 - Puracap Pharmaceutical Llc

NDC 51013-415-14

Package Description: 2 BLISTER PACK in 1 CARTON > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Cold Flu And Sore Throat Relief with NDC 51013-415 is a a human over the counter drug product labeled by Puracap Pharmaceutical Llc. The generic name of Cold Flu And Sore Throat Relief is acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Puracap Pharmaceutical Llc

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.

Cold Flu And Sore Throat Relief 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
  • GUAIFENESIN 200 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 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.

  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN (UNII: 6O92ICV9RU)

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: Puracap Pharmaceutical Llc
Labeler Code: 51013
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: 08-29-2017 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 - 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".

* Please review the disclaimer below.

Cold Flu And Sore Throat Relief Product Label Images

Cold Flu And Sore Throat Relief 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 Softgel)

Acetaminophen 325 mg Dextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

Uses

  • Temporarily relieves:nasal congestionheadachecoughminor aches and painssore throattemporarily reduces feverhelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

  • Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take:more than 12 softgels in 24 hours, which is the maximum  daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks daily while using this productAllergy alertAcetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.Sore 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

  • 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 diseaseheart diseasediabeteshigh blood pressurethyroid diseasetrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occurpain, nasal congestion, or cough 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.

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. 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 12 liquid gels in any 24-hour period                                                                                              adults and children 12 years of age and older: take 2 liquid gels every 4 hourschildren under 12 years of age: do not use

Other Information

  • Store between 15-30°C (59-86°F)avoid excessive heat

Inactive Ingredients

FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

* Please review the disclaimer below.