NDC 49314-4253 Unishield Cold Relief

Phenylephrine Hcl

NDC Product Code 49314-4253

NDC CODE: 49314-4253

Proprietary Name: Unishield Cold 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: 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies. It works by narrowing the blood vessels in the nose area, reducing swelling and congestion.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
FR;12
Score: 1

NDC Code Structure

  • 49314 - Unishield

NDC 49314-4253-3

Package Description: 50 PACKET in 1 BOX > 2 TABLET in 1 PACKET

NDC Product Information

Unishield Cold Relief with NDC 49314-4253 is a a human over the counter drug product labeled by Unishield. The generic name of Unishield Cold Relief is phenylephrine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Unishield

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Unishield Cold 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
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
  • GUAIFENESIN 200 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.

  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

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: Unishield
Labeler Code: 49314
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: 03-01-2021 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 ("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".

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Unishield Cold Relief Product Label Images

Unishield Cold 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredients (in each tablet) Acetaminophen 325 mgDextromethorphan Hydrobromide 15 mgGuaifenesin 200 mg Phenylephrine Hydrochloride 5 mg

Otc - Purpose

PurposePain reliever/ fever reducerCough suppressantExpectorantNasal decongestant

Indications & Usage

Temporarily relieves these cold symptoms■ cough■ sore throat■ minor aches and pains■ headache■ nasal congestion■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productiveTemporarily reduces fever.

Warnings

WarningsLiver 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 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.

Otc - Do Not Use

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 have ever had an allergic reaction to this product or any of its ingredients■ 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.
■ no more than 10 days unless directed by a doctor

Otc - Ask Doctor

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)■ persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are■ taking the blood thinning drug warfarin

Otc - When Using

When using this product■ do not use more than directed

Otc - Stop Use

Stop use and ask a doctor if■ new symptoms occur■ redness or swelling is present■ pain or nasal congestion gets worse or lasts for more than 7 days■ fever gets worse or lasts for more than 3 days■ you get nervous, dizzy or sleepless■ cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. 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

Dosage & Administration

DirectionsAdults and children:(12 years and older)Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.Children under 12 yearsAsk a doctor

Other Safety Information

Other information■ store at room temperature 59º-86ºF (15º-30ºC)■ avoid excessive heat and humidity■ tamper evident sealed packets■ do not use any opened or torn packets

Inactive Ingredient

Inactive ingredientsmaltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid.

Otc - Questions

Questions or comments? 800-480-5855

Unishield Cold Relief Label

Cold ReliefMulti-Symptom100 Tablets/ 1 Tablet Per PacketAcetaminophen 325 mgDextromethorphan HBr 15 mgGuaifenesin 200 mgPhenylephrine HCl 5 mgPull To OpenThis package is for Households Without Young Children.• Pain reliever/fever reducer• Quiets coughs• Loosens phlegm and thins broncial secretions• Relieves sinus congestantRelieves coughs, minor aches, headache, congestion & feverTamper Evident Unit Dose PacketsCompare active ingredients to:Sudafed PE®Registered Trademark of McNeil Consumer HealthcareTamper Evident Unit Dose Packets

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