Cvs 44-013 Hbp

SPL v10

SPL

SPL Set ID 146c9a62-0418-4b5d-9074-5be8a05f3f93

Route

ORAL

Published

Effective Date 2025-08-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Polyethylene Glycol 400 Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Saccharin Sodium Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-12-04

Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Uses

temporarily relieves common cold and flu symptoms:
- headache
- minor aches and pains
- sore throat
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
temporarily reduces fever

Warnings

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

more than 4,000 mg of acetaminophen in 24 hours
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.

Directions

do not take more than directed
do not exceed 4 doses per 24 hours
mL = milliliter
only use the dose cup provided
adults and children 12 years and over: 30 mL every 6 hours
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

Other Information

each 30 mL contains: sodium 13 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 69842-086-02

♥︎CVS_™

Cherry Flavor

Nighttime

HIGH BLOOD

PRESSURE

COLD & FLU

Acetaminophen

Pain Reliever, Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Doxylamine Succinate

Antihistamine

Compare to Vicks^® NyQuil™

High Blood Pressure Cold & Flu

active ingredients*

Decongestant Free for People

with High Blood Pressure

Multi-Symptom Relief: Aches & fever,

Runny nose, Sneezing, Cough

12 FL OZ (355 mL)

Ages 12 Years

& Older

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or

distributed by The Procter & Gamble

Company, owner of the registered

trademark Vicks^® NyQuil™ High Blood

Pressure Cold & Flu.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com^®

1-800-SHOP CVS

V-19849

50844 ORG032301302

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CVS 44-013

When Using This Product

excitability may occur, especially in children
avoid alcoholic beverages
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

pain or cough gets worse or lasts more than 7 days
redness or swelling is present
fever gets worse or lasts more than 3 days
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,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have

difficulty in urination due to enlargement of the prostate gland
liver disease
glaucoma
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much 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 common cold and flu symptoms:
- headache
- minor aches and pains
- sore throat
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
temporarily reduces fever

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Warnings

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

more than 4,000 mg of acetaminophen in 24 hours
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.

Directions

do not take more than directed
do not exceed 4 doses per 24 hours
mL = milliliter
only use the dose cup provided
adults and children 12 years and over: 30 mL every 6 hours
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

Other Information (Other information)

each 30 mL contains: sodium 13 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

NDC 69842-086-02

♥︎CVS_™

Cherry Flavor

Nighttime

HIGH BLOOD

PRESSURE

COLD & FLU

Acetaminophen

Pain Reliever, Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Doxylamine Succinate

Antihistamine

Compare to Vicks^® NyQuil™

High Blood Pressure Cold & Flu

active ingredients*

Decongestant Free for People

with High Blood Pressure

Multi-Symptom Relief: Aches & fever,

Runny nose, Sneezing, Cough

12 FL OZ (355 mL)

Ages 12 Years

& Older

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or

distributed by The Procter & Gamble

Company, owner of the registered

trademark Vicks^® NyQuil™ High Blood

Pressure Cold & Flu.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com^®

1-800-SHOP CVS

V-19849

50844 ORG032301302

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CVS 44-013

When Using This Product (When using this product)

excitability may occur, especially in children
avoid alcoholic beverages
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

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

pain or cough gets worse or lasts more than 7 days
redness or swelling is present
fever gets worse or lasts more than 3 days
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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

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

difficulty in urination due to enlargement of the prostate gland
liver disease
glaucoma
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much 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 common cold and flu symptoms: headache minor aches and pains sore throat runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever", "Purpose": "Pain reliever/fever reducer Cough suppressant Antihistamine", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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.", "Directions": "do not take more than directed do not exceed 4 doses per 24 hours mL = milliliter only use the dose cup provided adults and children 12 years and over: 30 mL every 6 hours 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", "Other information": "each 30 mL contains: sodium 13 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package", "Inactive ingredients": "anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose", "Questions or comments?": "1-800-426-9391", "Principal display panel": "NDC 69842-086-02 ♥︎CVS ™ Cherry Flavor Nighttime HIGH BLOOD PRESSURE COLD & FLU Acetaminophen Pain Reliever, Fever Reducer Dextromethorphan HBr Cough Suppressant Doxylamine Succinate Antihistamine Compare to Vicks ® NyQuil™ High Blood Pressure Cold & Flu active ingredients* Decongestant Free for People with High Blood Pressure Multi-Symptom Relief : Aches & fever, Runny nose, Sneezing, Cough 12 FL OZ (355 mL) Ages 12 Years & Older TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks ® NyQuil™ High Blood Pressure Cold & Flu. Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-19849 50844 ORG032301302 PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org CVS 44-013", "When using this product": "excitability may occur, especially in children avoid alcoholic beverages marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "pain or cough gets worse or lasts more than 7 days redness or swelling is present fever gets worse or lasts more than 3 days 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,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Active ingredients (in each 30 mL)": "Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg", "Ask a doctor before use if you have": "difficulty in urination due to enlargement of the prostate gland liver disease glaucoma a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much 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: 2026-02-15T12:06:44.491078 · Updated: 2026-03-14T23:09:41.311223