Cvs Health ™ - DailyMed Details

Cvs Health ™

SPL v8

SPL

SPL Set ID 6cb1d08b-e544-4084-b9ed-1e0d99a709c8

Route

ORAL

Published

Effective Date 2025-12-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg) Doxylamine (650 mg)

Inactive Ingredients

Anhydrous Citric Acid Maltodextrin Potassium Citrate Silicon Dioxide Sucralose Sucrose Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-07-14

Description

SEVERE COLD + FLU DAYTIME Drug Facts

Medication Information

Description

SEVERE COLD + FLU DAYTIME Drug Facts

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

Section 42229-5

SEVERE COLD + FLU DAYTIME

Drug Facts

Section 50565-1

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.

Section 50567-7

When using this product do not exceed recommended dosage

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1

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

Directions

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

Do Not Use

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

Allergy Alert

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.

Liver Warning

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

Other Information

each packet contains: potassium 6 mg
store at room temperature

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.

Inactive Ingredients

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

Questions Or Comments?

1-866-467-2748

When Using This Product

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

Principal Display Panel

C ompare 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

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.

Stop Use and Ask A Doctor If

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

Ask A Doctor Before Use If You Have

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)

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

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

Section 42229-5 (42229-5)

SEVERE COLD + FLU DAYTIME

Drug Facts

Section 50565-1 (50565-1)

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)

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

Directions

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

Do Not Use (Do not use)

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

Allergy Alert (ALLERGY ALERT)

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.

Liver Warning (Liver warning)

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

Other Information (Other information)

each packet contains: potassium 6 mg
store at room temperature

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL-)

C ompare 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

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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "SEVERE COLD + FLU DAYTIME Drug Facts", "50565-1": "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.", "50567-7": "When using this product do not exceed recommended dosage", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "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", "Directions": "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", "Do not use": "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", "ALLERGY ALERT": "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.", "Liver warning": "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", "Other information": "each packet contains: potassium 6 mg store at room temperature", "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.", "Inactive ingredients": "anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6", "Questions or comments?": "1-866-467-2748", "When using this product": "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", "PRINCIPAL DISPLAY PANEL-": "C ompare 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.", "Stop use and ask a doctor if": "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", "Ask a doctor before use if you have": "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)", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.570294 · Updated: 2026-03-14T23:11:05.615438