Label: COLD FAID- cold faid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 22, 2019

If you are a consumer or patient please visit this version.

  • PURPOSE

    GOOD SENSE NASAL DECONGESTANT PE

    Purpose: Nasal Decongestant

    CHLORPHEN -12

    Purpose: Antihistamine

    GOOD SENSE NAPROXEN SODIUM

    Purpose: Pain reliever/fever reducer

    Close
  • DOSAGE & ADMINISTRATION

    GOOD SENSE NASAL DECONGESTANT PE

    Dosage & Administration:

    Phenylephrine HCl 10 mg

    adults and children 12 years and over:

    • take 1 tablet every 4 hours
    • do not take more than 6 tablets in 24 hours

    children under 12 years, ask a doctor

    CHLORPHEN-12

    Dosage & Administration:

    Chlorpheniramine Maleate 12 mg, film coated, Extended Release

    • adults and children 12 years and over: 1 tablet every 12 hours.

    Do not exceed 2 tablets in 24 hours.

    • children under 12 years of age: ask a doctor

    GOOD SENSE NAPROXEN SODIUM

    Dosage & Administration:

    Naproxen Sodium 220 mg

    • do not take more than directed
    • the smallest effective dose should be used
    • drink a full glass of water with each dose

    Adults and children 12 years and older:

    • take 1 tablet every 8-12 hours while symptoms last
    • for the first dose you may take 2 tablets within the first hour
    • do not exceed 2 tablets in any 8-12 hour period
    • do not exceed 3 tablets in a 24-hour period

    Children under 12 years:

    • ask a doctor
    Close
  • INACTIVE INGREDIENT

    GOOD SENSE NASAL DECONGESTANT PE

    Inactive 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 dioxide

    CHLORPHEN-12

    Inactive ingredients:

    calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner's sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2 / indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate

    GOOD SENSE NAPROXEN SODIUM

    Inactive ingredients:

    FD&C blue No. 2 aluminum lake, hypomellose, magnesium stearate, microcrystalline celluose, polyethylene glycol, povidone, talc, titanium dioxide

    Close
  • WARNINGS

    GOOD SENSE NASAL DECONGESTANT PE

    Warnings:

    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 have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes

    When using this product do not exceed recommended dose.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever

    If 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).

    CHLORPHEN-12

    Warnings:

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis,
    • glaucoma
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmicist before use if you are taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

    If 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.

    GOOD SENSE NAPROXEN SODIUM

    Warnings:

    Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin.

    Symptoms may include:

    • hives
    • facial swelling
    • asthama (wheezing)
    • shock
    • skin reddening
    • rash blisters

    If 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 older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Heart 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 reducer
    • righ t before or after heart surgery

    Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you high blood pressure, heart disease , liver cirrhosis, kidney disease asthma,or had a stroke
    • you are taking a diuretic
    • you have problems or serious side effects from taing a pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product, ‚Äč

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    you experience any of the following signs of stomach bleeding:

    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better

    you have symptoms of heart problems or stroke;

    • chest pain
    • trouble breathing
    • weakness in one part or side of your body
    • slurred speech
    • leg swelling

    pain gets worse or lasts more than 10 days

    fever gets worse or lasts for more than 3 days

    you have difficulty swallowing

    it feels like the pill is stuck in your throat

    redness or swelling is present in the painful area

    any new symptoms appear

    If 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).

    Close
  • KEEP OUT OF REACH OF CHILDREN

    Good Sense Nasal Decongestant PE

    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).

    Chlorphen-12

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Good Sense Naproxen Sodium

    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).

    Close
  • INDICATIONS & USAGE

    INDICATIONS & USAGE SECTION

    GOOD SENSE NASAL DECONGESTANT PE

    Indications & Usage:

    temporarily relieves sinus congestion and pressure
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

    CHLORPHEN-12

    Indications & 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 SODIUM

    Indications & 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

    Close
  • PRINCIPAL DISPLAY PANEL

    123

    GOOD SENSE NASAL DECONGESTANT PE

    Active Ingredient: Phenylephrine HCl 10 mg

    CHORPHEN-12

    Active Ingredient: Chlorpheniramine Maleate 12 mg

    GOOD SENSE NAPROXEN SODIUM

    Active Ingredients: Naproxen Sodium - (naproxen 200 mg)

    Close
  • INGREDIENTS AND APPEARANCE
    COLD FAID 
    cold faid kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72996-001
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72996-001-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 05/06/2019
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1
    Part 2
    Part 3
    Part 1 of 3
    CHLORPHEN-12 
    chlorpheniramine maleate tablet, film coated, extended release
    Product Information
    Item Code (Source) NDC:10702-017
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 12 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SUCROSE (UNII: C151H8M554)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code Chlorphen;12
    Contains     
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040829 05/06/2019
    Part 2 of 3
    GOOD SENSE NASAL DECONGESTANT PE 
    phenylephrine hydrochloride tablet
    Product Information
    Item Code (Source) NDC:0113-0094
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    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)  
    Product Characteristics
    Color red Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code L7
    Contains     
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/06/2019
    Part 3 of 3
    GOOD SENSE NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Item Code (Source) NDC:0113-0901
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    Product Characteristics
    Color blue Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code L490
    Contains     
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074661 05/06/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/06/2019
    Labeler - Cold FAid (081373869)
    Establishment
    Name Address ID/FEI Business Operations
    Wayne County Chapter NYSARC Inc 085997732 pack(72996-001) , label(72996-001) , manufacture(72996-001)
    Close