Cold FAid by Cold FAid COLD FAID kit

Cold FAid by

Drug Labeling and Warnings

Cold FAid by is a Otc medication manufactured, distributed, or labeled by Cold FAid. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

GOOD SENSE NASAL DECONGESTANT PE

Purpose: Nasal Decongestant

CHLORPHEN -12

Purpose: Antihistamine

GOOD SENSE NAPROXEN SODIUM

Purpose: Pain reliever/fever reducer

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

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

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, ​

• 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).

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).

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

PRINCIPAL DISPLAY PANEL

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)

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		1
Part 2		1
Part 3		1

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

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

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

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)