ACETAMINOPHEN SINUS CONGESTION AND PAIN

Manufacturer
A P J Laboratories Limited
Effective date
2013-06-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:35:39

Label at a glance#

ProductACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

■ Do not take more than directed (see overdose warning) ■ Adults and children 12 years and over: Take 2 gelcaps every 4 hoursdo not take more than 12 gelcaps in 24 hours ■ Children under 12 years: Do not use this adult product in children under 12 years of age

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACETAMINOPHEN 325 mg

PHENYLEPHRINE HYDROCHLORIDE 5mg

OTC - PURPOSE SECTION

•Alleviates Sinus Headache & Pain (Acetaminophen)

•Relieves Sinus Pressure Clears Nasal Congestion (Phenylephrine HCl)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

for the temporary relief of:

• headache

•sinus

•congestion and pressurenasal congestion

•minor aches and pains

•helps decongest sinus openings and passages

•promotes sinus drainage

•helps clear nasal passages

WARNINGS SECTION

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

■ more than 12 gelcaps in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Overdose warning:

■ Taking more than the recommended dose (overdose) may cause liver damage.

■ In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Do not take more than directed (see overdose warning)

■ Adults and children 12 years and over: Take 2 gelcaps every 4 hoursdo not take more than 12 gelcaps in 24 hours

■ Children under 12 years: Do not use this adult product in children under 12 years of age

INACTIVE INGREDIENT SECTION

•CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

•CELLULOSE, MICROCRYSTALLINE

•STARCH, CORN

•BUTYLATED HYDROXYTOLUENE

•METHYLPARABEN

•PROPYLPARABEN

•SODIUM STARCH GLYCOLATE TYPE A POTATO

•TALC

•MAGNESIUM STEARATE

•SALICYLIC ACID

•CROSCARMELLOSE SODIUM

•SODIUM LAURYL SULFATE

•ISOPROPYL ALCOHOL

•METHYLENE CHLORIDE

•TITANIUM DIOXIDE

•HYPROMELLOSES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ProductProduct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSN4
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD4
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46084-101-302019-11-27C16284748780-19855d018-e7e3-cd31-e053-dbdaa90ab51a44a25c50-b16b-407c-99ea-668afca25924

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46084-101-30ACETAMINOPHEN SINUS CONGESTION AND PAINA P J COATED30 in 1 BLISTER PACKTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46084-101ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]4Legacy NDC, 1 package rows20130607_44a25c50-b16b-407c-99ea-668afca25924.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ4
ACETAMINOPHENACTIVE MOIETY362O9ITL9D4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92J4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH484
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163024
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I304
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0A4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A24
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ4
TALCINACTIVE INGREDIENT7SEV7J4R1U4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP4

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46084-10146084-101-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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 8 · 459 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAVENOUS5 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJDROPS / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, ORALLY DISINTEGRATING / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FOR SUSPENSION / ORAL20100 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE PELLETS / ORAL127 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / SUBLINGUAL1.1 mgExact identifier — unii candidate
42 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii candidate
42 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JOINTMENT / TOPICAL14 mgExact identifier — unii candidate
42 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSUSPENSION, EXTENDED RELEASE / ORAL0.08 mg/1mlExact identifier — unii candidate
42 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48PELLET / ORAL162 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYSTEM / TOPICAL54 mgExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates

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
529b0e8e-4f74-4d96-b9dc-c57ba66162d344a25c50-b16b-407c-99ea-668afca259242013-06-06WarningsExact identifier
spl id: 529b0e8e-4f74-4d96-b9dc-c57ba66162d3
spl set id: 44a25c50-b16b-407c-99ea-668afca25924

Reported adverse events (FAERS/openFDA)#

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