FDA.reportPublic FDA data

sinus relief

Manufacturer
Kroger Company
Effective date
2019-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:51:20

Label at a glance#

Productsinus relief
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

• temporarily relieves: • nasal congestion • headache • minor aches and pains • sinus congestion and pressure • runny nose and sneezing (NIGHT only) • cough (NIGHT only) • temporarily promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)

Dosage and administration

• do not take more than directed (see Overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years of age and older: take 2 caplets every 4 hours • children under 12 years of age: do not use

Storage and handling

• each caplet contains: sodium 4 mg (DAY only) • store at 20-25 ° C (68-77 ° F)

Label contents#

Full prescribing information#

Active ingredients (in each caplet) SINUS RELIEF Day

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever

Expectorant

Nasal decongestant

Active ingredients (in each caplet) SINUS RELIEF Night

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever

Antihistamine/cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
  • nasal congestion
  • headache
  • minor aches and pains
  • sinus congestion and pressure
  • runny nose and sneezing (NIGHT only)
  • cough (NIGHT only)
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)

Warnings

WARNINGS SECTION

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using these products

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
  • with any other product containing diphenhydramine, even one used on skin (NIGHT only)
  • 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 these products.
  • if you have ever had an allergic reaction to these products or any of their ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (NIGHT only)

When using these products

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children (NIGHT only)
  • marked drowsiness may occur (NIGHT only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
  • avoid alcoholic drinks (NIGHT only)
  • be careful when driving a motor vehicle or operating machinery (NIGHT only)

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 more than 7 days
  • fever gets worse or lasts 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: 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)
  • do not take more than 10 caplets in any 24-hour period
  • adults and children 12 years of age and older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 4 mg (DAY only)
  • store at 20-25°C (68-77°F)

Inactive ingredients (DAY only)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive ingredients (NIGHT only)

INACTIVE INGREDIENT SECTION

crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-632-6900

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredients of MUCINEX® SINUS-MAX®

See side panel

FOR AGES 12+

MAXIMUM STRENGTH

Sinus Relief

DayTime

Acetaminophen, Pain Reliever

Guaifenesin, Expectorant

Phenylephrine HCl, Nasal Decongestant

Relieves Sinus Pressure, Headache & Congestion

Thins & Loosens Mucus

actual size

10 CAPLETS

Night Time

Acetaminophen, Pain Reliever

Diphenhydramine HCl, Antihistamine

Cough Suppressant

Phenylephrine HCl, Nasal Decongestant

Relieves Nasal Congestion, Sinus Pressure & Pain

Relieves Runny Nose, Sneezing & Cough

10 CAPLETS

actual size

sinus relief image 1
sinus relief image 1
sinus relief image 2
sinus relief image 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-415-902025-02-05C16284748780-12cef2736-b4db-d83d-e063-dadaa90ab31fKroger Co. Sinus Relief Drug Facts
30142-415-902025-01-30C16284748780-12cef2736-b4db-d83d-e063-dadaa90ab31fKroger Co. Sinus Relief Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-41530142-415-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

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
bdb34ca4-31d7-4e6f-8b49-b5b286ad3a4ce11fc990-e29c-4cd5-893f-5dbb52772ab02025-02-04WarningsExact identifier
spl set id: e11fc990-e29c-4cd5-893f-5dbb52772ab0

Reported adverse events (FAERS/openFDA)#

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