FDA.reportPublic FDA data

Day and Night Multi Symptom Cold and Flu Relief

Manufacturer
Intrivo Diagnostics Inc.
Effective date
2023-10-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:01:57

Label at a glance#

ProductDay and Night Multi Symptom Cold and Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure9 sections

Dosage and administration

Directions (Nighttime only) take only as directed do not exceed 4 doses per 24 hours Adults and children 12 years and over: 2 softgels with water every 4 hours Children 4 to under 12 years: do not use Children under 4 years:  ask a doctor Directions (Daytime only) take only as directed do not exceed 4 doses per 24 hours Adults and children 12 years and over: 2 softgels with water every 6 hours Children 4 to under ...

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each softgel)
Nighttime only
Acetaminophen 325mg
 Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg

Active Ingredients (in each softgel)
Daytime only
Acetaminophen 325mg
Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

OTC - PURPOSE SECTION

Nighttime only
Pain reliever/fever reducer
Cough suppressant
Antihistamine

Daytime only
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Use(s)

INDICATIONS & USAGE SECTION

temporarily relieves common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains 
  • fever
  • runny nose and sneezing
  • nasal congestion (Daytime only)

Warnings

WARNINGS SECTION


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

  • more than 4 doses 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, lasts for more
than 2 days, occurs with or followed by fever, headache, rash,
nausea, or vomiting, see 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 drugs. If you do not know if your
    prescription drug contains an MAOI, ask a doctor or pharmacist
    before taking this product

  • to make a child sleep (Nighttime only)

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • liver disease
  • 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 emphysema
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (Nighttime only)
  • heart disease
  • thyroid disease
  • diabetes high blood sugar (Daytime only)

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking the blood thinning drug warfarin

  •  taking sedatives or tranquilizers (Nighttime only)

When using this product

OTC - WHEN USING SECTION

When using this product

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain 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.
  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults) (Daytime only)
    These could be signs of a serious condition.

If pregnant or breastfeeding,

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

Taking more than directed can cause serious health problems. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions (Nighttime only)

  • take only as directed
  • do not exceed 4 doses per 24 hours
    Adults and children 12 years and over: 2 softgels with water every 4 hours
    Children 4 to under 12 years: do not use
    Children under 4 years:  ask a doctor

Directions (Daytime only)

  • take only as directed
  • do not exceed 4 doses per 24 hours
    Adults and children 12 years and over: 2 softgels with water every 6 hours
    Children 4 to under 12 years: do not use
    Children under 4 years:  ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 20-25 °C (68-77° F)
  • do not use if blister unit is torn or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients (Nighttime only)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol sorbitan
solution, white edible ink

Inactive ingredients (Daytime only)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone,
propylene glycol, purified water, sorbitol sorbitan solution, white
edible ink

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Daytime and Nighttime softgels
Daytime and Nighttime softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCK2
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN2
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN2
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN2
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD2
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY2
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83558-020-02Day and Night Multi Symptom Cold and Flu Relief2 in 1 CARTONKIT22
83558-020-02Day and Night Multi Symptom Cold and Flu Relief1 in 1 CARTONKIT12
83558-021-01Day and Night Multi Symptom Cold and Flu Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105 mg2
83558-021-01Day and Night Multi Symptom Cold and Flu Relief1 in 1 CARTONCAPSULE, LIQUID FILLED5 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83558-020DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF KIT [INTRIVO DIAGNOSTICS INC.]2Current NDC, 4 package rows20231114_a311bf39-de6c-4ed5-949e-718ad8be1e49.zip
83558-021DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF KIT [INTRIVO DIAGNOSTICS INC.]2Unmatched20231114_a311bf39-de6c-4ed5-949e-718ad8be1e49.zip

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
83558-02083558-020-02
83558-02183558-021-01
83558-022

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT

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
Day and Night Multi Symptom Cold and Flu ReliefDAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEFIntrivo Diagnostics Inc.a311bf39-de6c-4ed5-949e-718ad8be1e492023-10-13WarningsExact identifier
ndc (package): 83558-021-01
ndc (package): 83558-020-02
ndc (product): 83558-020
ndc11 (package): 83558002101
ndc11 (package): 83558002002
spl id: 6c999083-433a-481f-9ae4-cd0ca9e12e86
spl set id: a311bf39-de6c-4ed5-949e-718ad8be1e49

Reported adverse events (FAERS/openFDA)#

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