DAYTIME and NIGHTTIME SEVERE COLD AND FLU

Manufacturer
CVS PHARMACY
Effective date
2021-11-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:41

Label at a glance#

ProductDAYTIME and NIGHTTIME SEVERE COLD AND FLU DAYTIME NON DROWSY NIGHTTIME
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE
Label structure28 sections

Indications and uses

■ temporarily relieves common cold/flu symptoms: ■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ minor aches & 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 (mucus) and thin bronchial secretions to rid the bronchial ...

Dosage and administration

■ take only as directed - see Overdose warning ■ do not exceed 4 doses per 24 hours  adults & children 12 years & over  2 softgels with water every 4 hours  children 4 to under 12 years  ask a doctor  children under 4 years  do not use ■ when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Storage and handling

■ store at room temperature

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

OTC - PURPOSE SECTION

Active ingredients (in each softgel)                                Purposes
Acetaminophen 325 mg............................Pain reliever/fever reducer
Dextromethorphan HBr 10 mg.............................Cough suppressant
Guaifenesin 200 mg.........................................................Expectorant
Phenylephrine HCl 5 mg......................................Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves common cold/flu symptoms:
■ nasal congestion ■ sinus congestion & pressure
■ cough due to minor throat & bronchial irritation
■ minor aches & 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 (mucus) 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 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

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

WARNINGS SECTION

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.

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 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

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 use more than directed.

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

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.

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

Taking more than directed can cause serious
health problems. In case of overdose, get medical help or contact a
Poison Control Center 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

INDICATIONS & USAGE SECTION

■ take only as directed - see Overdose warning
■ do not exceed 4 doses per 24 hours

 adults & children 12 years & over 2 softgels with water every
4 hours
 children 4 to under 12 years ask a doctor
 children under 4 years do not use

■ when using other Nighttime or Daytime products, carefully read
each label to ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

■ store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan , titanium dioxide

SPL UNCLASSIFIED SECTION

NIGHTTIME SEVERE COLD & FLU SOFTGELS

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

OTC - PURPOSE SECTION

Active ingredients (in each softgel)                              Purposes
Acetaminophen 325 mg............................Pain reliever/fever reducer
Dextromethorphan HBr 10 mg.............................Cough suppressant
Doxylamine succinate 6.25 mg.....................................Antihistamine
Phenylephrine HCl 5 mg......................................Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

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

WARNINGS SECTION

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.

WARNINGS SECTION

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.

NIGHTTIME SEVERE COLD & FLU SOFTGELS

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

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.
■ to make a child sleep

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 emphysema
■ trouble urinating due to enlarged prostate gland

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

When using this product

OTC - WHEN USING SECTION

■ do not use more than directed
■ 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

NIGHTTIME SEVERE COLD & FLU SOFTGELS

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

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.

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

Taking more than directed can cause serious
health problems. In case of overdose, get medical help or contact a
Poison Control Center right away. Quick medical attention is critical
for adults as well as for children even if you do not notice any signs
or symptoms.

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ take only as directed - see Overdose warning
■ do not exceed 4 doses per 24 hours

 adults & children 12 years & over 2 softgels with water every
4 hours
 children 4 to under 12 years ask a doctor
 children under 4 years do not use

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Yellow No. 10, FD&C Blue No. 1,
gelatin, glycerin, polyethylene glycol, povidone, propylene glycol,
purified water, sorbitol sorbitan, sodium hydroxide†, titanium dioxide
†may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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) } PackGPCK2
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) PackPSN2
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN2
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN2
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
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) PackSY2
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-818-242023-01-30C16284748780-1f386c649-ae4d-0266-e053-dadaa90a7c1aCVS Health Non-Drowsy Daytime Severe Cold & Flu and Nighttime Severe Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-818-24DAYTIME and NIGHTTIME SEVERE COLD AND FLUDAYTIME NON DROWSY NIGHTTIME1 in 1 PACKAGE, COMBINATIONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-818DAYTIME AND NIGHTTIME SEVERE COLD AND FLU DAYTIME NON DROWSY NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [CVS PHARMACY]2Legacy NDC, 1 package rows20211103_ca68a507-2865-d99a-e053-2a95a90a5f20.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-81869842-818-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 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
cfbdbf45-7321-1ea6-e053-2995a90a820aca68a507-2865-d99a-e053-2a95a90a5f202021-11-01WarningsExact identifier
spl id: cfbdbf45-7321-1ea6-e053-2995a90a820a
spl set id: ca68a507-2865-d99a-e053-2a95a90a5f20

Reported adverse events (FAERS/openFDA)#

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