Indications and uses
temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
ADVIL COLD AND SINUS - Haleon US Holdings LLC
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2026-07-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 14
- Source
- daily-update
- Hydrated at
- 2026-08-01 05:10:13
Label at a glance#
ProductADVIL COLD AND SINUS
Active ingredientIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used. do not use more than 6 capsules in any 24-hour period unless directed by a doctor children under 12 years of age: do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each liquid-filled capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
Pseudoephedrine HCl 30 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Nasal decongestant
Uses
temporarily relieves these symptoms associated with the common cold or flu:
- headache
- fever
- sinus pressure
- nasal congestion
- minor body aches and pains
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (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 nonprescription 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
- in children under 12 years of age
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs 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
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking any other product that contains pseudoephedrine or any other nasal decongestant
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- 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 body
- slurred speech
- leg swelling
- fever gets worse or lasts more than 3 days
- nasal congestion lasts for more than 7 days
- symptoms continue or get worse
- redness or swelling is present in the painful area
- you get nervous, dizzy, or sleepless
- any new symptoms appear
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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 contact a Poison Control Center right away.
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years of age and over:
- take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used.
- do not use more than 6 capsules in any 24-hour period unless directed by a doctor
- children under 12 years of age: do not use
Other information
- each capsule contains: potassium 20 mg
- store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
- read all warnings and directions before use. Keep carton.
Inactive ingredients
D&C yellow no. 10, FD&C red no. 40, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution
Questions or comments?
Call weekdays from 9 AM to 5 PM ESTtoll free at 1-800-88-ADVIL
Additional Information
READ AND KEEP CARTON FOR COMPLETEWARNINGS AND INFORMATION
Product inside sealed in plastic blister with foil backing.
Do Not Use if plastic blister or foil barrier is broken.
PRINCIPAL DISPLAY PANEL
Advil
COLD & SINUS Non-Drowsy
Ibuprofen 200 mg ‣ Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine HCl 30 mg ‣ Nasal Decongestant
Relieves Sinus Pressure,
Nasal Congestion and Fever
LIQUI-GELS®
Advil
C & S
32 LIQUID-FILLED CAPSULES
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0573-0184-16 | 2024-01-31 | C162847 | 48780-1 | 0191ceaa-70a6-198a-e063-dbdaa90aec3e | Drug Facts |
| 0573-0184-16 | 2024-01-31 | C162847 | 48780-1 | 0191ceaa-70a6-198a-e063-dbdaa90aec3e | Drug Facts |
| 0573-0184-32 | 2024-01-31 | C162847 | 48780-1 | 0191ceaa-70a6-198a-e063-dbdaa90aec3e | Drug Facts |
| 0573-0184-32 | 2024-01-31 | C162847 | 48780-1 | 0191ceaa-70a6-198a-e063-dbdaa90aec3e | Drug Facts |
| 0573-0184-16 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-70a6-198a-e063-dbdaa90aec3e | Drug Facts |
| 0573-0184-16 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-70a6-198a-e063-dbdaa90aec3e | Drug Facts |
| 0573-0184-32 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-70a6-198a-e063-dbdaa90aec3e | Drug Facts |
| 0573-0184-32 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-70a6-198a-e063-dbdaa90aec3e | Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0573-0184-32 | EA - Each | 0573-0184 | f7d60135-daba-4533-9171-6da0a7e01d43 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | 4 | |
| pseudoephedrine hydrochloride | ACTIVE INGREDIENT | 6V9V2RYJ8N | 4 | |
| ibuprofen | ACTIVE MOIETY | WK2XYI10QM | 4 | |
| pseudoephedrine | ACTIVE MOIETY | 7CUC9DDI9F | 4 | |
| coconut acid | INACTIVE INGREDIENT | 40U37V505D | 4 | |
| D&C yellow no. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 4 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 4 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | 4 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 4 | |
| potassium hydroxide | INACTIVE INGREDIENT | WZH3C48M4T | 4 | |
| sorbitan | INACTIVE INGREDIENT | 6O92ICV9RU | 4 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 4 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Products#
Every source-derived product name is available through these pages.
- ADVIL COLD AND SINUS
- ibuprofen, pseudoephedrine hydrochloride
- IBUPROFEN
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- D&C YELLOW NO. 10
- FD&C RED NO. 40
- GELATIN, UNSPECIFIED
- MEDIUM-CHAIN TRIGLYCERIDES
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POTASSIUM HYDROXIDE
- WATER
- SORBITOL
- SORBITAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0573-0184 | 0573-0184-32, 0573-0184-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 13 | 2025-09-11 | full-release | 2026-06-01 01:13:27 |
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| sorbitol | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| coconut acid | COCONUT ACID | 40U37V505D | SOAP / TOPICAL | 7 %w/w | ||
| potassium hydroxide | POTASSIUM HYDROXIDE | WZH3C48M4T | CAPSULE, LIQUID FILLED / ORAL | 154 mg | ||
| sorbitol | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| sorbitol | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| coconut acid | COCONUT ACID | 40U37V505D | SHAMPOO / TOPICAL | 3 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| sorbitol | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| sorbitol | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| coconut acid | COCONUT ACID | 40U37V505D | SOLUTION / TOPICAL | 0.7 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| coconut acid | COCONUT ACID | 40U37V505D | SOAP / TOPICAL | 7 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| potassium hydroxide | POTASSIUM HYDROXIDE | WZH3C48M4T | CAPSULE, LIQUID FILLED / ORAL | 154 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| sorbitol | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| coconut acid | COCONUT ACID | 40U37V505D | SHAMPOO / TOPICAL | 3 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| sorbitan | SORBITAN | 6O92ICV9RU | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| sorbitan | SORBITAN | 6O92ICV9RU | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, LIQUID FILLED / ORAL | 1.51 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| sorbitan | SORBITAN | 6O92ICV9RU | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| potassium hydroxide | POTASSIUM HYDROXIDE | WZH3C48M4T | CAPSULE, LIQUID FILLED / ORAL | 154 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| coconut acid | COCONUT ACID | 40U37V505D | SHAMPOO / TOPICAL | 3 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| coconut acid | COCONUT ACID | 40U37V505D | SOLUTION / TOPICAL | 0.7 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| coconut acid | COCONUT ACID | 40U37V505D | SOLUTION / TOPICAL | 0.7 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg |
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 |
|---|---|---|---|---|---|---|---|
| N021374-001 | ADVIL COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 |
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 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021374-001 | ADVIL COLD AND SINUS | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | RLD, RS | 2002-05-30 | 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 |
|---|---|---|---|---|---|---|
| ADVIL COLD AND SINUS | IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE | Haleon US Holdings LLC | 0da9ed22-bfb4-d61b-110b-0c7760332a98 | 2026-07-29 | Warnings | 0573-0184-16 0573-0184-32 0573-0184 00573018432 00573018416 57c53749-0be1-d204-e063-6394a90a2704 0da9ed22-bfb4-d61b-110b-0c7760332a98 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.