Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID fc7954a6-d061-4160-b1d1-a19eb9eabff4

Route

ORAL

Published

Effective Date 2024-04-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)

Inactive Ingredients

Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Lecithin, Soybean Fd&c Red No. 40 Gelatin Polyethylene Glycol, Unspecified Sorbitol Povidone Sorbitan Light Mineral Oil Mannitol

Identifiers & Packaging

Pill Appearance

Imprint: PC9 Shape: oval Color: orange Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-04-30

Description

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg

Uses

temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- nasal congestion
- cough due to minor throat and bronchial irritation

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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

more than 4,000 mg of acetaminophen I 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks everyday while using this product

Allery 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 (see overdose warning)
do not take more than 4 doses in 24-hour period
adults and children 12 years and over: take 2 softgels with water every 4 hours
swallow whole; do not crush, chew, or dissolve
children under 12 years: do not use
When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Do Not Use

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.
with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Package Label

QUALITYCHOICE Non-Drowsy Day Time Cold and Flu Relief

Other Information

store between 15-30ºC (59-86º)
avoid excessive heat

Inactive Ingredients

FD&C yellow #6, FD&C red #40, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol white ink

Questions Or Comments?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the Active Ingredients in VICKS® DAYQUIL® COLD & FLU LIQUICAPS®

Non-Drowsy

Day Time

Multi-Symptom Relief For Cold/Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever | Fever Reducer

Cough Suppressant | Nasal Decongestant

Non-Drowsy | Alcohol Free | Antihistamine Free

Softgels

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OR TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® DayQuil® and LiquiCaps® are registered trademarks of The Procter & Gamble Company.

Distributed by C.D.M.A., Inc©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

When Using This Product,

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

pain, cough or nasal congestion gets worse or lasts more than 7 days
nervousness, dizziness, or sleeplessness occur
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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

Ask A Doctor Before Use If the User Has

liver disease
heart disease
thyroid disease
diabetes
high blood pressure
persistent or chronic cough such as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- nasal congestion
- cough due to minor throat and bronchial irritation

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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

more than 4,000 mg of acetaminophen I 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks everyday while using this product

Allery 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 (see overdose warning)
do not take more than 4 doses in 24-hour period
adults and children 12 years and over: take 2 softgels with water every 4 hours
swallow whole; do not crush, chew, or dissolve
children under 12 years: do not use
When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Do Not Use (Do not use)

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.
with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Package Label

QUALITYCHOICE Non-Drowsy Day Time Cold and Flu Relief

Other Information (Other information)

store between 15-30ºC (59-86º)
avoid excessive heat

Inactive Ingredients (Inactive ingredients)

FD&C yellow #6, FD&C red #40, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol white ink

Questions Or Comments? (Questions or comments?)

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the Active Ingredients in VICKS® DAYQUIL® COLD & FLU LIQUICAPS®

Non-Drowsy

Day Time

Multi-Symptom Relief For Cold/Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever | Fever Reducer

Cough Suppressant | Nasal Decongestant

Non-Drowsy | Alcohol Free | Antihistamine Free

Softgels

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OR TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® DayQuil® and LiquiCaps® are registered trademarks of The Procter & Gamble Company.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

When Using This Product, (When using this product,)

do not exceed recommended dosage.

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
nervousness, dizziness, or sleeplessness occur
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.

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 Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

Ask A Doctor Before Use If the User Has (Ask a doctor before use if the user has)

liver disease
heart disease
thyroid disease
diabetes
high blood pressure
persistent or chronic cough such as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)
trouble urinating due to an enlarged prostate gland

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation", "Purposes": "Pain reliever/fever reducer Cough suppressant Nasal decongestant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen I 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product Allery 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 (see overdose warning) do not take more than 4 doses in 24-hour period adults and children 12 years and over: take 2 softgels with water every 4 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing", "Do not use": "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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.", "Package Label": "QUALITYCHOICE Non-Drowsy Day Time Cold and Flu Relief", "Other information": "store between 15-30ºC (59-86º) avoid excessive heat", "Inactive ingredients": "FD&C yellow #6, FD&C red #40, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol white ink", "Questions or comments?": "Call 1-800-935-2362 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "†Compare to the Active Ingredients in VICKS® DAYQUIL® COLD & FLU LIQUICAPS® Non-Drowsy Day Time Multi-Symptom Relief For Cold/Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl Pain Reliever | Fever Reducer Cough Suppressant | Nasal Decongestant Non-Drowsy | Alcohol Free | Antihistamine Free Softgels TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OR TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® DayQuil® and LiquiCaps® are registered trademarks of The Procter & Gamble Company. Distributed by C.D.M.A., Inc© 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com", "When using this product,": "do not exceed recommended dosage .", "Stop use and ask a doctor if": "pain, cough or nasal congestion gets worse or lasts more than 7 days nervousness, dizziness, or sleeplessness occur 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.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.", "Active ingredients (in each softgel)": "Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg", "Ask a doctor before use if the user has": "liver disease heart disease thyroid disease diabetes high blood pressure persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:59.861616 · Updated: 2026-03-14T23:02:50.389879