NDC 72996-003 Cold Faid

Cold Faid

NDC Product Code 72996-003

NDC Product Information

Cold Faid with NDC 72996-003 is a a human over the counter drug product labeled by Cold Faid. The generic name of Cold Faid is cold faid. The product's dosage form is kit and is administered via oral form.

Labeler Name: Cold Faid

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • TALC (UNII: 7SEV7J4R1U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • TALC (UNII: 7SEV7J4R1U)
  • POVIDONE (UNII: FZ989GH94E)

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: Cold Faid
Labeler Code: 72996
Marketing Category: UNAPPROVED DRUG OTHER - 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: 02-01-2021 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 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’.

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Cold Faid Product Label Images

Cold Faid 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

Otc - Active Ingredient

GOOD SENSE NASAL DECONGESTANT PEActive Ingredient: Phenylephrine HCl 10 mgCHORPHEN-12Active Ingredient: Chlorpheniramine Maleate 12 mgGOOD SENSE NAPROXEN SODIUM Active Ingredients: Naproxen Sodium - (naproxen 200 mg)

Otc - Purpose

GOOD SENSE NASAL DECONGESTANT PEPurpose: Nasal DecongestantGOOD SENSE 4-HOUR ALLERGY RELIEFPurpose: AntihistamineGOOD SENSE NAPROXEN SODIUMPurpose: Pain reliever/fever reducer

Dosage & Administration

  • GOOD SENSE NASAL DECONGESTANT PEDosage & Administration:Phenylephrine HCl 10 mgadults and children 12 years and over:take 1 tablet every 4 hoursdo not take more than 6 tablets in 24 hourschildren under 12 years, ask a doctorGOOD SENSE 4-HOUR ALLERGY RELIEFDosage & Administration:Chlorpheniramine Maleate 4 mgadults and chilren 12 years and over:take 1 tablet every 4 to 6 hous, not to exceed 6 tablets in 24 hourschildren 6 to under 12 years of age:1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hourschildren 4 to under 6 years of age:do not use unless directed by a doctorChildren under 4 years of age:do not useGOOD SENSE NAPROXEN SODIUMDosage & Administration:Naproxen Sodium 220 mgdo not take more than directedthe smallest effective dose should be useddrink a full glass of water with each doseAdults and children 12 years and older:take 1 tablet every 8-12 hours while symptoms lastfor the first dose you may take 2 tablets within the first hourdo not exceed 2 tablets in any 8-12 hour perioddo not exceed 3 tablets in a 24-hour periodChildren under 12 years:ask a doctor

Inactive Ingredient

GOOD SENSE NASAL DECONGESTANT PEInactive ingredients:anhydrous dibasic calcium, phosphate, camauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxideGOOD SENSE 4-HOUR ALLERGY RELIEFInactive ingredients:D&C yellow No. 10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starchGOOD SENSE NAPROXEN SODIUMInactive ingredients:FD&C blue No. 2 aluminum lake, hypomellose, magnesium stearate, microcrystalline celluose, polyethylene glycol, povidone, talc, titanium dioxide

Warnings

  • GOOD SENSE NASAL DECONGESTANT PEWarnings:Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drug 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 haveheart diseasehigh blood pressurethyroid diseasediabetesWhen using this product do not exceed recommended dose. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occursymptoms do not improve within 7 days or occur with a feverIf pregnant or breast-feeding, ask a health professional before use.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poision Control Center right away (1-800-222-1222).
  • GOOD SENSE 4-HOUR ALLERGY RELIEFWarnings:Do notuse to make a child sleepyAsk a doctor before use if you have a breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to enlarged prostate glandAsk a doctor or pharmicist before use if you are taking sedatives or tranquilizers
  • When using this productexcitability may occur, especially in childrendrowsiness may occuravoid alcoholic beveragesalcohol, sedatives and tranquilizers may increase drowsinessuse caution when driving a motor vehicle or operating machineryIf pregnant or breast-feeding, ask a health professional before use.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800222-1222).
  • Do not use if blister unit is broken or tornGOOD SENSE NAPROXEN SODIUMWarnings:Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin.
  • Symptoms may include:hivesfacial swellingasthama (wheezing)shockskin reddeningrash blistersIf an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • Are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
  • Do not use if you have ever had an allergic reaction to another pain reliever/fever reducerrigh
  • T before or after heart surgeryAsk a doctor before use if the stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou high blood pressure, heart disease , liver cirrhosis, kidney disease asthma,or had a strokeyou are taking a diureticyou have problems or serious side effects from taing a pain relievers or fever reducersAsk a doctor or pharmacist before use if you areunder a doctor's care for any serious conditiontaking any other drugWhen using this product, ​
  • Take with food or milk if stomach upset occursStop use and ask a doctor ifyou experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke;chest paintrouble breathingweakness in one part or side of your bodyslurred speechleg swellingpain gets worse or lasts more than 10 daysfever gets worse or lasts for more than 3 daysyou have difficulty swallowingit feels like the pill is stuck in your throatredness or swelling is present in the painful areaany new symptoms appearIf pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
  • Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away (1-800-222-1222).

Otc - Keep Out Of Reach Of Children

GOOD SENSE NASAL DECONGESTANT PEKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
GOOD SENSE 4-HOUR ALLERGY RELIEFKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
(1-800-222-1222).GOOD SENSE NAPROXEN SODIUMKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Indications & Usage

INDICATIONS & USAGE SECTIONGOOD SENSE NASAL DECONGESTANT PEIndications & Usage:temporarily relieves sinus congestion and pressure

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
GOOD SENSE 4-HOUR ALLERGY RELIEFIndications & Usage:temporarily relieves the following symptoms due to hayfever, or other respiratory allergies:sneezing,

runny nose,

itchy, watery eyes,

itching of the nose or throat
GOOD SENSE NAPROXEN SODIUMIndications & Usage:temporarily relieves minor aches and pains due to:minor pain of arthritis

muscular aches

backache

menstrual cramps

headache

toothache

the common cold
temporarily reduces fever

Recent Major Changes

INDICATIONS & USAGE, Subsection Heading: Contents, Sequence 7, Changed information for Good Sense 4-Hour Allergy Relief, 08/2020DOSAGE & ADMINISTRATION, Subsection Heading: Contents, Sequence 7, Changed information for Good Sense 4-Hour Allergy Relief,08/2020WARNINGS& PRECAUTIONS, Subsection Heading: Contents, Sequence 7, Changed information for Good Sense 4-Hour Allergy Relief, 08/2020

* Please review the disclaimer below.