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
Ibuprofen and Pseudoephedrine hydrochloride
- Manufacturer
- Ohm Laboratories Inc. | Ranbaxy Pharmaceuticals Inc.
- Effective date
- 2025-02-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 00:56:11
Label at a glance#
ProductIbuprofen and Pseudoephedrine hydrochloride
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 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use
Storage and handling
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.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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)
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 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
- do not use more than 6 caplets in any 24-hour period unless directed by a doctor
- children under 12 years of age: do not use
Other information
- 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
acacia, calcium carbonate, carnauba wax, confectioner's sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax
Questions?
call 1-800-406-7984
SPL UNCLASSIFIED SECTION
Distributed by: Ohm Laboratories Inc.
North Brunswick, NJ 08902
PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton
†Compare To
the active ingredients of
Advil
®Cold & Sinus
NDC 51660-423-21
See New Warnings Information
ohm ®
Non-Drowsy
Cold & Sinus
Ibuprofen and Pseudoephedrine
HCl Tablets, USP
Ibuprofen, USP 200 mg – Pain Reliever/Fever Reducer (NSAID)*
Pseudoephedrine HCl, USP 30 mg – Nasal Decongestant
*nonsteroidal anti-inflammatory drug
- Relieves Sinus Pressure,
Nasal Congestion and Fever
20 Coated Caplets**
(**oval-shaped tablets)
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51660-423-21 | Ibuprofen and Pseudoephedrine hydrochloride | 20 in 1 BLISTER PACK | TABLET, SUGAR COATED | 20 | 7 | |
| 51660-423-41 | Ibuprofen and Pseudoephedrine hydrochloride | 40 in 1 BLISTER PACK | TABLET, SUGAR COATED | 40 | 7 |
DailyMed Dashboard NDC Coverage#
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 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | 4 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 4 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 4 | |
| GUAR GUM | INACTIVE INGREDIENT | E89I1637KE | 4 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | 4 | |
| KAOLIN | INACTIVE INGREDIENT | 24H4NWX5CO | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 4 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 4 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 4 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 4 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | 4 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 4 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | 4 |
Products#
Every source-derived product name is available through these pages.
- Ibuprofen and Pseudoephedrine hydrochloride
- ACACIA
- CALCIUM CARBONATE
- CARNAUBA WAX
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- CROSPOVIDONE (15 MPA.S AT 5%)
- FD&C BLUE NO. 2
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN, UNSPECIFIED
- KAOLIN
- POVIDONE, UNSPECIFIED
- POWDERED CELLULOSE
- PROPYLENE GLYCOL
- SHELLAC
- SILICON DIOXIDE
- SODIUM BENZOATE
- SUCROSE
- TALC
- TITANIUM DIOXIDE
- WHITE WAX
- GUAR GUM
- FERROSOFERRIC OXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- IBUPROFEN
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51660-423 | 51660-423-21, 51660-423-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ACACIA | ACACIA | 5C5403N26O | CAPSULE / ORAL | 20 mg | ||
| GUAR GUM | GUAR GUM | E89I1637KE | TABLET, FILM COATED / ORAL | 36 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE / ORAL | 349.9 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | FILM, SOLUBLE / ORAL | 14 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, CHEWABLE / ORAL | 1650 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SOLUTION / ORAL | 98 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE, DELAYED RELEASE / ORAL | 0.22 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, CHEWABLE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE, DELAYED RELEASE / ORAL | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, FILM COATED / ORAL | 0.14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SUSPENSION / ORAL | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / ORAL | 60.02 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE / ORAL | 4 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | CAPSULE, EXTENDED RELEASE / ORAL | 204 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, CHEWABLE / ORAL | 121 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE / ORAL | 349.9 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, EXTENDED RELEASE / ORAL | 864 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, DELAYED RELEASE / ORAL | 0.08 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, DELAYED RELEASE / ORAL | 0.2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA |
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 |
|---|---|---|---|---|---|---|---|
| A074567-001 | IBUPROHM COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2001-04-17 |
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 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 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 |
|---|---|---|---|---|---|---|
| Ibuprofen and Pseudoephedrine hydrochloride | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | Ohm Laboratories Inc. | 65ec0f85-7ca3-4adc-b152-a0ae2fd0692f | 2025-02-27 | Warnings | 51660-423-41 51660-423-21 51660-423 51660042341 51660042321 2f1cab21-cfa7-0b0e-e063-6294a90a9ae6 65ec0f85-7ca3-4adc-b152-a0ae2fd0692f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.