FDA.reportPublic FDA data

CVS Health

Manufacturer
CVS Pharmacy,Inc.
Effective date
2026-08-14
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-18 02:03:20

Label at a glance#

ProductSEVERE COLD PLUS FLU DAYTIME NIGHTTIME
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure17 sections

Indications and uses

▪ temporarily relieves these symptoms due to a cold or flu: ▪ minor aches and pains ▪ headache ▪ sore throat ▪ cough ▪ nasal congestion ▪ sinus congestion and pressure ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ▪ temporarily reduces fever

Dosage and administration

▪ do not take more than the recommended dose ▪ take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor ▪ adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. ▪ children under 12 years: do not use

Storage and handling

▪ each packet contains: potassium 6 mg ▪ store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION


SEVERE COLD + FLU DAYTIME

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each packet)Purposes

Acetaminophen 500 mg

Pain reliever/fever reducer

Dextromethorphan hydrobromide 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

Phenylephrine hydrochloride 10 mg

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • sore throat
    • cough
    • nasal congestion
    • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 6 packets 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

ADVERSE REACTIONS SECTION

  • Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
  • Is a skin or general allergic reaction occurs, stop use and seek medical help right away.
  • Skin reddening
  • Blisters
  • Rash
  • Hives
  • facial swelling
  • asthma(wheezing)
  • shock

    Is a skin or general allergic reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

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
  • in children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough with excessive 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

  • pain, cough, or nasal congestion 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.
  • nervousness, dizziness, or sleeplessness occurs

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. In case of overdose, get medical help or contact a Poison Control Center right away at 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 the recommended dose
  • take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
  • adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each packet contains: potassium 6 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

SPL UNCLASSIFIED SECTION

SEVERE COLD + FLU NIGHTTIME

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each packet)Purposes

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan hydrobromide 20 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

Phenylephrine hydrochloride 10 mg

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold or flu:
    • headache
    • minor aches and pains
    • cough
    • sore throat
    • nasal congestion
    • sinus congestion and pressure
    • runny nose
    • sneezing
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 5 packets 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

ADVERSE REACTIONS SECTION

  • Acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddening
  • Blisters
  • Rash
  • Hives
  • facial swelling
  • asthma (wheezing)
  • shock

Is a skin or general allergic reaction occurs, stop use and seek medical help right away

Sore throat warning

SPL UNCLASSIFIED SECTION

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 to sedate children.

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
  • in children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain, cough, or nasal congestion 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.
  • nervousness, dizziness, or sleeplessness occurs

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. In case of overdose, get medical help or contact a Poison Control Center right away at 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 the recommended dose
  • take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
  • adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each packet contains: potassium 6 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL-

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Alka-Seltzer PLUS® Severe Cold +Flu Day and Night Active Ingredients*

DAYTIME

SEVERE COLD & FLU

Acetaminophen / Pain reliever-fever reducer

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant
Phenylephrine HCl / Nasal decongestant

Relieves:
• Nasal Congestion • Headache
• Sore Throat • Body Ache • Cough
• Mucus • Chest Congestion • Fever

Honey Lemon Flavor

Naturally and Artificially Flavored

NIGHTTIME

Severe Cold & Flu

Acetaminophen / Pain reliever-fever reducer

Dextromethorphan HBr / Cough suppressant
Doxylamine succinate / Antihistamine
Phenylephrine HCl / Nasal decongestant

Relieves:

• Nasal Congestion • Headache
• Sore Throat • Body Ache
• Cough • Runny Nose • Fever

Honey Lemon Flavor

Naturally and Artificially Flavored

TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL POUCH IS TORN OR OPEN

DO NOT TAKE THESE PRODUCTS AT THE SAME TIME

6 DAY PACKETS + 6 NIGHT PACKETS
12 TOTAL

Distributed by: CVS Pharmacy, Inc.

One CVS Drive Woonsocket, RI 02895

©2017 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Money Back Guarantee

*These products is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Alka-Seltzer plus® Severe Cold +Flu Day and Night.

Severe Cold Plus Flu Daytime and Nighttime Honey Lemon Flavor
Severe Cold Plus Flu Daytime and Nighttime Honey Lemon Flavor

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

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
69842-54669842-546-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MALTODEXTRIN7CVR7L4A2DIACT
POTASSIUM CITRATEEE90ONI6FFIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MALTODEXTRIN7CVR7L4A2DIACT
POTASSIUM CITRATEEE90ONI6FFIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
FD&C YELLOW NO. 6H77VEI93A8IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-08full-release2026-06-01 01:20:40

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
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
ndc (package): 69842-546-12
ndc (product): 69842-546
ndc11 (package): 69842054612
spl id: b31ebbd7-009f-410c-b09e-e666a6f0d9cd
spl set id: 6cb1d08b-e544-4084-b9ed-1e0d99a709c8

Reported adverse events (FAERS/openFDA)#

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