Cold FAid

Manufacturer
Cold FAid | The Arc of Monroe
Effective date
2021-07-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:39:59

Label at a glance#

ProductCold FAid
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, NAPROXEN SODIUM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

GoddSense Nasal Decongestant PE

Active Ingredient: Phenylephrine HCl 10 mg

GoodSense Allergy Relief

Active Ingredient: Chlorpheniramine Maleate 4 mg

GoodSense Naproxen Sodium

Active Ingredients: Naproxen Sodium 220 mg (naproxen 200 mg)

BestHealth Zinc Lozenges

Active Ingredients: Zinc Gluconate 13.3 mg

OTC - PURPOSE SECTION

GOOD SENSE NASAL DECONGESTANT PE

Purpose: Nasal Decongestant

GOOD SENSE 4-HOUR ALLERGY RELIEF

Purpose: Antihistamine

GOOD SENSE NAPROXEN SODIUM

Purpose: Pain reliever/fever reducer

DOSAGE & ADMINISTRATION SECTION

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

GOOD SENSE 4-HOUR ALLERGY RELIEF

Dosage & Administration:

Chlorpheniramine Maleate 4 mg

adults and chilren 12 years and over:

  • take 1 tablet every 4 to 6 hous, not to exceed 6 tablets in 24 hours

children 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 hours

children 4 to under 6 years of age:

  • do not use unless directed by a doctor

Children under 4 years of age:

  • do not use

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 SECTION

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

GOOD SENSE 4-HOUR ALLERGY RELIEF

Inactive ingredients:

D&C yellow No. 10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch

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 SECTION

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).

GOOD SENSE 4-HOUR ALLERGY RELIEF

Warnings:

Do notuse to make a child sleepy

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

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 (1-800222-1222).

Do not use if blister unit is broken or torn

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).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).

GOOD SENSE 4-HOUR ALLERGY RELIEF

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).

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

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

GOOD SENSE 4-HOUR ALLERGY RELIEF

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

RECENT MAJOR CHANGES SECTION

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

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BBAAGood Sense Decongestant PEGood Sense Decongestant PEGood Sense Decongestant PEGood Sense Decongestant PEGood Sense Allergy ReliefGood Sense Allergy Relief

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0042-62EA - Each0113-004238dc13c2-3e68-4ccb-9b84-15539a8de3dd12024-06-10
0113-0042-78EA - Each0113-0042dfda3b4c-5e84-40a3-b064-0db6cb12b23212018-07-03
0113-0094-23EA - Each0113-0094f58f0d09-9254-497a-9ab6-102ae064bb7c12012-07-24
0113-0094-68EA - Each0113-0094e7fb255f-5d97-4342-9122-b303526c4b9412012-07-24
0113-0094-89EA - Each0113-0094d84cdf73-3ad7-4fea-b987-f3295de68f0c12012-07-24
0113-4368-62EA - Each0113-4368bc67d066-2a1e-4806-a7c1-e232b732e93b12018-02-20
0113-4368-71EA - Each0113-4368993338e5-109e-4ef6-9be0-b5f443412b5712018-02-20
0113-4368-76EA - Each0113-436844440010-53b4-4de7-9f66-fda678f65a3512024-02-14
0113-4368-78EA - Each0113-4368e8dafb0f-462d-4fc5-bfb9-c6567df41bbd12017-03-06
0113-4368-79EA - Each0113-43684abd9a15-8206-4d60-bf29-504433dc3b2912023-03-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72996-00372996-003-01
0113-0042
0113-0094
0113-4368

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074661-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL1997-01-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1384e616aacf4f…
2026-08-18 06:07:402026-07A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A074661-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1997-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A074661-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1997-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Naproxen SodiumNAPROXEN SODIUML. Perrigo Company8e150c00-8e5b-40b4-a964-cb70442c27522026-05-11WarningsExact identifier
ndc (product): 0113-4368
ebcbe75b-5285-2fa6-e053-2a95a90a3c0fb9bc8383-84f4-3fa2-e053-2a95a90a1ebf2022-10-24WarningsExact identifier
spl set id: b9bc8383-84f4-3fa2-e053-2a95a90a1ebf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.