Severe DayTime NightTime Cold and Flu Relief

Manufacturer
YET HEALTH GROUP LLC
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:06:34

Label at a glance#

ProductSevere DayTime NightTime Cold and Flu Relief Max Strength
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure25 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation cough to help you sleep minor aches and pains headache fever sore throat runny nose and sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

Dosage and administration

take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

store at room temperature; do not exceed 25°C (77°F)

Label contents#

Full prescribing information#

NIGHTTIME SEVERE COLD & FLU Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

DAYTIME SEVERE COLD & FLU Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

NIGHTTIME SEVERE COLD & FLU Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

DAYTIME SEVERE COLD & FLU Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

NIGHTTIME SEVERE COLD & FLU Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

DAYTIME SEVERE COLD & FLU Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (musus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

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

  • more than 8 softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

NIGHTTIME SEVERE COLD & FLU Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

DAYTIME SEVERE COLD & FLU 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
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

NIGHTTIME SEVERE COLD & FLU Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

DAYTIME SEVERE COLD & FLU Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

NIGHTTIME SEVERE COLD & FLU When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

DAYTIME SEVERE COLD & FLU When using this product

OTC - WHEN USING SECTION

do not use more than directed.

NIGHTTIME SEVERE COLD & FLU Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you gets nervous, dizzy or sleepless
  • 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.

DAYTIME SEVERE COLD & FLU Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • 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

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

NIGHTTIME SEVERE COLD & FLU Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

DAYTIME SEVERE COLD & FLU Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • do not exceed 8 softgels per 24 hrs
adults & children 12 yrs & overtake 2 softgels with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature; do not exceed 25°C (77°F)

NIGHTTIME SEVERE COLD & FLU Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C YELLOW #10, FD&C BLUE #1, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SODIUM HYDROXIDE, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

DAYTIME SEVERE COLD & FLU Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C YELLOW #6, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

Questions?

OTC - QUESTIONS SECTION

CALL TOLL-FREE 1-844-735-0202

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_B-B_Daytime-Nighttime Severe Cold-Flu Relief_80-4001b UC_B-B_Daytime-Nighttime Severe Cold-Flu Relief_80-40

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634364{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCK6
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSN6
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN6
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN6
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD6
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD6
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSY6
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY6
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81179-004-00Severe DayTime NightTime Cold and Flu ReliefMax Strength1 in 1 BOTTLECAPSULE, LIQUID FILLED405 mg6
81179-008-00Severe DayTime NightTime Cold and Flu ReliefMax Strength1 in 1 BOTTLECAPSULE, LIQUID FILLED8010 mg6
81179-804-02Severe DayTime NightTime Cold and Flu ReliefMax Strength1 in 1 BOTTLEKIT16
81179-804-02Severe DayTime NightTime Cold and Flu ReliefMax Strength1 in 1 CARTONKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81179-004SEVERE DAYTIME NIGHTTIME COLD AND FLU RELIEF MAX STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL, GUAIFENESIN) KIT [YET HEALTH GROUP LLC]6Unmatched20240104_cc33f772-a42b-0c11-e053-2995a90a7a23.zip
81179-008SEVERE DAYTIME NIGHTTIME COLD AND FLU RELIEF MAX STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL, GUAIFENESIN) KIT [YET HEALTH GROUP LLC]6Unmatched20240104_cc33f772-a42b-0c11-e053-2995a90a7a23.zip
81179-804SEVERE DAYTIME NIGHTTIME COLD AND FLU RELIEF MAX STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL, GUAIFENESIN) KIT [YET HEALTH GROUP LLC]6Legacy NDC, 4 package rows20240104_cc33f772-a42b-0c11-e053-2995a90a7a23.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81179-80481179-804-02
81179-00481179-004-00
81179-00881179-008-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

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
0e12a47e-7acd-fe31-e063-6294a90a4917cc33f772-a42b-0c11-e053-2995a90a7a232024-01-03WarningsExact identifier
spl id: 0e12a47e-7acd-fe31-e063-6294a90a4917
spl set id: cc33f772-a42b-0c11-e053-2995a90a7a23

Reported adverse events (FAERS/openFDA)#

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