COLD FAID- cold faid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)
Available from:
Cold FAid
Prescription type:
OTC DRUG
Therapeutic indications:
GOOD SENSE NASAL DECONGESTANT PE Purpose: Nasal Decongestant CHLORPHEN -12 Purpose: Antihistamine GOOD SENSE NAPROXEN SODIUM Purpose: Pain reliever/fever reducer 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
Authorization status:
unapproved drug other
Authorization number:
72996-001-01

COLD FAID- cold faid

Cold FAid

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.

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GOOD SENSE NASAL DECONGESTANT PE

Purpose: Nasal Decongestant

CHLORPHEN -12

Purpose: Antihistamine

GOOD SENSE NAPROXEN SODIUM

Purpose: Pain reliever/fever reducer

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

GOOD SENSE NASAL DECONGESTANT PE

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

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).

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 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

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)

COLD FAID

cold faid kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:729 9 6 -0 0 1

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:729 9 6 -0 0 1-0 1

1 in 1 KIT; Type 1: Co nvenience Kit o f Co -Package

0 5/0 6 /20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

Pa rt 2

Pa rt 3

Part 1 of 3

CHLORPHEN-12

chlorpheniramine maleate tablet, film coated, extended release

Product Information

Ite m Code (Source )

NDC:10 70 2-0 17

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

12 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

GELATIN (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

TALC (UNII: 7SEV7J4R1U)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

SUCRO SE (UNII: C151H8 M554)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

METHACRYLIC ACID - ETHYL ACRYLATE CO PO LYMER ( 1:1) TYPE A (UNII: NX76 LV5T8 J)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CALCIUM SULFATE (UNII: WAT0 DDB50 5)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

HYDRO XYPRO PYL CELLULO SE, LO W SUBSTITUTED (UNII: 216 5RE0 K14)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

Product Characteristics

Color

o ra nge

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

Chlo rphe n;12

Contains

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 8 29

0 5/0 6 /20 19

Part 2 of 3

GOOD SENSE NASAL DECONGESTANT PE

phenylephrine hydrochloride tablet

Product Information

Ite m Code (Source )

NDC:0 113-0 0 9 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

TALC (UNII: 7SEV7J4R1U)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

Product Characteristics

Color

re d

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

Contains

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 5/0 6 /20 19

Part 3 of 3

GOOD SENSE NAPROXEN SODIUM

naproxen sodium tablet, film coated

Product Information

Ite m Code (Source )

NDC:0 113-0 9 0 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NAPRO XEN SO DIUM (UNII: 9 TN8 7S3A3C) (NAPROXEN - UNII:57Y76 R9 ATQ)

NAPROXEN SODIUM

220 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

TALC (UNII: 7SEV7J4R1U)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

Product Characteristics

Color

blue

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

L49 0

Contains

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 746 6 1

0 5/0 6 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 5/0 6 /20 19

Labeler -

Cold FAid (081373869)

Establishment

Cold FAid

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Wayne Co unty Chapter NYSARC Inc

0 8 59 9 7732

pack(729 9 6 -0 0 1) , label(729 9 6 -0 0 1) , manufacture(729 9 6 -0 0 1)

Revised: 4/2019

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