Ibuprofen and Pseudoephedrine Hydrochloride

Manufacturer
HEB | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date
2018-04-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:55:13

Label at a glance#

ProductIbuprofen and Pseudoephedrine Hydrochloride
Active ingredientIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections

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

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purposes

Ibuprofen, USP 200 mg (NSAID)*

Pain reliever/fever reducer

Pseudoephedrine HCl, USP 30 mg

Nasal decongestant

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms associated with the common cold or flu:

  • headache
  • fever
  • sinus pressure
  • nasal congestion
  • minor body aches and pains

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 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.

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

call 1-800-406-7984

PRINCIPAL DISPLAY PANEL - 40 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to Advil® Cold & Sinus active ingredients

NDC 37808-423-40

H-E-B®

Cold & Sinus Relief

Ibuprofen, USP 200 mg / Pain Reliver/Fever Reducer (NSAID)*
Pseudoephedrine HCl, USP 30 mg / Nasal Decongestant

Cold & Sinus *nonsteroidal anti-inflammatory drug

Non-Drowsy

Relief of:

  • Fever • Sinus Pressure
  • Nasal Congestion

40 COATED CAPLETS**
(**oval-shaped tablets)

actual
size

PRINCIPAL DISPLAY PANEL - 40 Caplet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 40 Caplet Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299021ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral TabletPSN4
1299021ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-423-402020-01-31C16284748780-19d75b9d0-d534-f424-e053-dadaa90a57ceH-E-B ® Cold & Sinus Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-423-40Ibuprofen and Pseudoephedrine Hydrochloride40 in 1 BLISTER PACKTABLET, SUGAR COATED404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-423IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEB]4Legacy NDC, 1 package rows20180417_421a0a2b-4238-4f1f-8824-6b3468f33470.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM3
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8N3
IBUPROFENACTIVE MOIETYWK2XYI10QM3
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9F3
ACACIAINACTIVE INGREDIENT5C5403N26O3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH483
CROSPOVIDONEINACTIVE INGREDIENT68401960MK3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A83
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3573
GELATININACTIVE INGREDIENT2G86QN327L3
GUAR GUMINACTIVE INGREDIENTE89I1637KE3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671P3
KAOLININACTIVE INGREDIENT24H4NWX5CO3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A3
POVIDONEINACTIVE INGREDIENTFZ989GH94E3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9M3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
SHELLACINACTIVE INGREDIENT46N107B71O3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ3
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJ3
SUCROSEINACTIVE INGREDIENTC151H8M5543
TALCINACTIVE INGREDIENT7SEV7J4R1U3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP3
TRISTEARININACTIVE INGREDIENTP6OCJ2551R3

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-42337808-423-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 11 · 642 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PPOWDER, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
27 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii candidate
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET, EXTENDED RELEASE / ORAL156 mgExact identifier — unii candidate
16 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / PERIODONTAL3.44 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, COATED PELLETS / ORAL41.4 mgExact identifier — unii candidate
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, COATED PELLETS / ORAL198 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION / ORAL11 mgExact identifier — unii candidate
34 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii candidate
30 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / SUBLINGUALNAExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
11 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER, FOR SUSPENSION / ORAL735 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, FILM COATED / ORAL0.14 mgExact identifier — unii candidate
19 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, SUSPENSION / INTRAMUSCULAR1.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EINJECTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, DELAYED RELEASE / ORAL8 mgExact identifier — unii candidate
13 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48GRANULE / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
27 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESYSTEM / TOPICAL41 mgExact identifier — unii candidate
30 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE, EXTENDED RELEASE / ORAL21 mgExact identifier — unii candidate
13 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / BUCCAL0.01 mgExact identifier — unii candidate
11 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates

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 44.

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
A074567-001IBUPROHM COLD AND SINUSIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2001-04-17

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17c2088c7a36db…
2026-09-14 22:38:342026-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1784e616aacf4f…
2026-08-18 06:07:402026-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173a93d1ddd44b…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1ddb4081-dedd-44c8-b634-185ff2c9b908421a0a2b-4238-4f1f-8824-6b3468f334702018-04-17WarningsExact identifier
spl id: 1ddb4081-dedd-44c8-b634-185ff2c9b908
spl set id: 421a0a2b-4238-4f1f-8824-6b3468f33470

Reported adverse events (FAERS/openFDA)#

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