FDA.reportPublic FDA data

SohMed Sinus

Manufacturer
Sohm Inc.
Effective date
2013-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:49

Label at a glance#

ProductSohMed Sinus
Active ingredientAcetaminophen, Guaifenesin, Phenylephrine Hydrochloride
Label structure11 sections

Indications and uses

for the temporary relief of : sinus congestion and pressure headache nasal congestion minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold, and hay fever and other upper respiratory allergies

Dosage and administration

adults and children 12 years and over take 1-2 caplets every 4 hours as needed do not take more than 8 caplets in 24 hours children under 12 years consult a doctor

Storage and handling

avoid excessive heat and humidity store between 15°-30°C (59°-86°f) See end flap for expiration date and lot number

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)purpose
Acetaminophen 325 mgPain reliever
Guaifenesin 200mgExpectorant
Phenylephrine HCL 5mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of :
    • sinus congestion and pressure
    • headache
    • nasal congestion
    • minor aches and pains
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
  • temporarily relieves nasal congestion due to the common cold, and hay fever and other upper respiratory allergies

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 8 caplets 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.

Although rare, possible reactions to consumption of acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of the skin. If you are taking this product and develop a rash or other skin reaction, stop taking this product immediately and seek medical attention.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • 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
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain nasal congestion or cough gets worse or lasts for more than 7 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a PoisonControl Center right away. Prompt 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

  • adults and children 12 years and over
    • take 1-2 caplets every 4 hours as needed
    • do not take more than 8 caplets in 24 hours
  • children under 12 years
    • consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • avoid excessive heat and humidity store between 15°-30°C (59°-86°f)
  • See end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, sodium lauryl sulphate, edetate disodium, dioctyl sodium sulphosuccinate, polyvinyl pyrollidone, gelatin, corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium benzoate, sodium starch glycolate, stearic acid, purified talc, titanium dioxide

Question or comments?

OTC - QUESTIONS SECTION

1(856) 2863646

SPL UNCLASSIFIED SECTION

Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C,
Buena Park, CA 90621

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SohMed™

NDC XXXXXXXXXX

*Compare to the active ingredients in Tylenol ® Sinus Congestion
& Pain Severe Day Time

SEVERE
Sinus Congestion & Pain Relief

Acetaminophen 325 mg, Guaifenesin 200 mg,
Phenylephrine HCl 5 mg

Relieves Sinus Pressure, Nasal Congestion and Fever

24 Caplets

Daytime
Non-Drowsy

Principal Display Panel - 24 Caplet Bottle Carton
Principal Display Panel - 24 Caplet Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN1
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50405-009-242020-01-31C16284748780-19d75b9d0-0058-f424-e053-dadaa90a57ceSohMed™ Sinus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50405-009-24SohMed Sinus24 in 1 BOTTLE, PLASTICTABLET241
50405-009-24SohMed Sinus1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50405-009SOHMED SINUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [SOHM INC.]1Legacy NDC, 2 package rows20130905_c0b0e4f1-bceb-4662-928b-c24730be0ba4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
GuaifenesinACTIVE INGREDIENT495W7451VQ1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
GuaifenesinACTIVE MOIETY495W7451VQ1
PhenylephrineACTIVE MOIETY1WS297W6MV1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
DI-2-HEXYL SODIUM SULFOSUCCINATEINACTIVE INGREDIENT772Y8KZU651
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GELATININACTIVE INGREDIENT2G86QN327L1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WE1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5Z1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6B1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

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
50405-00950405-009-24

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
Guaifenesin495W7451VQACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
EDETATE DISODIUM7FLD91C86KIACT
DI-2-HEXYL SODIUM SULFOSUCCINATE772Y8KZU65IACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K90RDH86HJV5ZIACT
GELATIN2G86QN327LIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 · 471 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, EXTENDED RELEASE / ORAL166 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSYSTEM / TOPICAL280 mgExact identifier — unii candidate
19 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii candidate
42 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / VAGINAL0.2 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii candidate
42 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET, DELAYED RELEASE / ORAL192 mgExact identifier — unii candidate
19 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000POLYETHYLENE GLYCOL 600030IQX730WEINSERT / VAGINAL0.06 mgExact identifier — unii candidate
15 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / SUBLINGUAL13 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION / TOPICAL120 mgExact identifier — unii candidate
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGRANULE / ORAL12 mgExact identifier — unii candidate
42 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 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
13d67cad-bab8-4bae-bbe9-d3e4a14bd501c0b0e4f1-bceb-4662-928b-c24730be0ba42013-08-21WarningsExact identifier
spl id: 13d67cad-bab8-4bae-bbe9-d3e4a14bd501
spl set id: c0b0e4f1-bceb-4662-928b-c24730be0ba4

Reported adverse events (FAERS/openFDA)#

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