Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID c08b150c-d821-466c-8521-f77535d6af1e

Route

ORAL

Published

Effective Date 2024-04-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

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

Inactive Ingredients

Butylated Hydroxyanisole Butylated Hydroxytoluene Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol Mannitol

Identifiers & Packaging

Pill Appearance

Imprint: P19 Shape: capsule Color: orange Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-03-31

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

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 (see Overdose warning)
do not take more than 4 doses in 24 hours
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 other Daytime or Nighttime products, carefully read each label to insure correct dosing

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.

Package Label

WELLNESS BASICS Cold and Flu Relief

Other Information

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

Inactive Ingredients

butylated hydroxyanisole, butylated hydroxytoluene, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

daytime multi-symptom

cold & flu relief

acetaminophen (pain reliever / fever reducer)

dextromethorphan HBr (cough suppressant)

phenylephrine HCl (nasal decongestant)

non-drowsy
Alcohol free
Antihistamine free

Softgels**

(**liquid-filled capsules)

†Compare to the active ingredients in Vicks® DayQuil® Cold & Flu LiquiCaps®

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

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 can cause liver damage. 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.

Ask A Doctor Before Use If You Have

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

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

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

Purpose

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 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 (see Overdose warning)
do not take more than 4 doses in 24 hours
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 other Daytime or Nighttime products, carefully read each label to insure correct dosing

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.

Package Label

WELLNESS BASICS Cold and Flu Relief

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

butylated hydroxyanisole, butylated hydroxytoluene, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

daytime multi-symptom

cold & flu relief

acetaminophen (pain reliever / fever reducer)

dextromethorphan HBr (cough suppressant)

phenylephrine HCl (nasal decongestant)

non-drowsy
Alcohol free
Antihistamine free

Softgels**

(**liquid-filled capsules)

†Compare to the active ingredients in Vicks® DayQuil® Cold & Flu LiquiCaps®

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

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.)

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

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

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

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 common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation", "Purpose": "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 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 (see Overdose warning) do not take more than 4 doses in 24 hours 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 other Daytime or Nighttime products, carefully read each label to insure correct dosing", "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.", "Package Label": "WELLNESS BASICS Cold and Flu Relief", "Other information": "store between 15-30ºC (59-86ºF) avoid excessive heat", "Inactive ingredients": "butylated hydroxyanisole, butylated hydroxytoluene, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "daytime multi-symptom cold & flu relief acetaminophen (pain reliever / fever reducer) dextromethorphan HBr (cough suppressant) phenylephrine HCl (nasal decongestant) non-drowsy Alcohol free Antihistamine free Softgels** (**liquid-filled capsules) †Compare to the active ingredients in Vicks® DayQuil® Cold & Flu LiquiCaps® †This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil®, and LiquiCaps® are registered trademarks of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWING ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: PL Developments 200 Hicks Street, Westbury, NY 11590", "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 can cause liver damage. 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.", "Ask a doctor before use if you have": "liver disease diabetes heart disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)", "Active ingredients (in each softgel)": "Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg", "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: 2026-02-15T12:03:02.513174 · Updated: 2026-03-14T23:02:53.135799