Cold FAid
- Manufacturer
- Cold FAid | The Arc of Monroe
- Effective date
- 2021-01-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:55:16
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
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)
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
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-0042-62 | EA - Each | 0113-0042 | 38dc13c2-3e68-4ccb-9b84-15539a8de3dd | 1 | 2024-06-10 |
| 0113-0042-78 | EA - Each | 0113-0042 | dfda3b4c-5e84-40a3-b064-0db6cb12b232 | 1 | 2018-07-03 |
| 0113-0094-23 | EA - Each | 0113-0094 | f58f0d09-9254-497a-9ab6-102ae064bb7c | 1 | 2012-07-24 |
| 0113-0094-68 | EA - Each | 0113-0094 | e7fb255f-5d97-4342-9122-b303526c4b94 | 1 | 2012-07-24 |
| 0113-0094-89 | EA - Each | 0113-0094 | d84cdf73-3ad7-4fea-b987-f3295de68f0c | 1 | 2012-07-24 |
| 0113-0901-62 | EA - Each | 0113-0901 | df0b0a83-6ddf-4f38-9f6a-4070204c84b4 | 1 | 2018-06-11 |
| 0113-0901-71 | EA - Each | 0113-0901 | fd3b8fb5-2092-4940-8ec5-094a5a4f3ee2 | 1 | 2023-01-09 |
| 0113-0901-75 | EA - Each | 0113-0901 | 6e147446-0cdc-4508-b89d-6bf6bda5efe7 | 1 | 2023-09-05 |
| 0113-0901-78 | EA - Each | 0113-0901 | d659e4b4-48f9-4803-b782-c0ac07fd8e99 | 1 | 2020-06-05 |
Products#
Every source-derived product name is available through these pages.
- Cold FAid
- Good Sense Allergy Relief
- chlorpheniramine maleate
- D&C YELLOW NO. 10
- MAGNESIUM STEARATE
- CHLORPHENIRAMINE
- LACTOSE MONOHYDRATE
- ANHYDROUS LACTOSE
- Good Sense Nasal Decongestant PE
- Phenylephrine hydrochloride
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- PHENYLEPHRINE
- CELLULOSE, MICROCRYSTALLINE
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SILICON DIOXIDE
- FD&C RED NO. 40
- CARNAUBA WAX
- TALC
- POLYVINYL ALCOHOL, UNSPECIFIED
- Good Sense Naproxen Sodium
- Naproxen Sodium
- NAPROXEN
- HYPROMELLOSES
- FD&C BLUE NO. 2
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72996-002 | 72996-002-01 |
| 0113-0042 | |
| 0113-0094 | |
| 0113-0901 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074661-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074661-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 1997-01-13 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074661-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 1997-01-13 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Good Sense Naproxen Sodium | NAPROXEN SODIUM | L. Perrigo Company | 6bc74cda-458c-480e-a33c-d2ba68d5e6bd | 2026-01-29 | Warnings | 0113-0901 |
| b9bc9feb-9332-d0f7-e053-2a95a90ad31e | 9ff606e1-6d77-615e-e053-2a95a90adbd8 | 2021-01-25 | Warnings | b9bc9feb-9332-d0f7-e053-2a95a90ad31e 9ff606e1-6d77-615e-e053-2a95a90adbd8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.




