Non-drowsy Daytime Cold & Flu Relief Softgels

SPL v1

SPL

SPL Set ID 38299cf3-e884-4676-8cc4-6dd64e7d023c

Route

ORAL

Published

Effective Date 2024-03-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Fd&c Yellow No. 6 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol Methylparaben Propylparaben Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: SN2 Shape: oval Color: orange Size: 21 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

nasal congestion
cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
sore throat

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.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 and for children even if you do not notice any signs or symptoms.

Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if youare taking the blood thinning drug warfarin.

Section 53414-9

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

Directions

take only as directed
do not exceed 4 doses per 24 hours

adults and children 12 years and over	take 2 softgels with water every 4 hours
children 4 to under 12 years	ask a doctor
children under 4 years	do not use

Do Not Use

with any other product containing acetaminophen (prescription or non-prescription). 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.

Questions?

1-800-630-8895

Distributed By:

Advanced Rx

1942 NE 163rd St,

North Miami Beach, FL 33162 U.S.A.

*This product is not manufactured or distributed by the owner of the registered trademark Vicks ^®DayQuil ^®Cold & Flu LiquiCaps ^®

Other Information

store at room temperature.
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, methyl paraben, propyl paraben, titanium dioxide

Principal Display Panel

NDC 80513-303-50

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

50 Softgels

NON-DROWSY

DAYTIME

COLD & FLU RELIFE

Acetaminophen,

Phenylephrine HCl,

Dextromethorphan HBr

Pain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant

Stop Use and Ask A Doctor If

you get nervous, dizzy or sleepless
pain, nasal congestion or cough 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.

Ask A Doctor Before Use If You Have

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

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

nasal congestion
cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
sore throat

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if youare taking the blood thinning drug warfarin.

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Directions

take only as directed
do not exceed 4 doses per 24 hours

adults and children 12 years and over	take 2 softgels with water every 4 hours
children 4 to under 12 years	ask a doctor
children under 4 years	do not use

Do Not Use (Do not use)

with any other product containing acetaminophen (prescription or non-prescription). 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.

Questions?

1-800-630-8895

Distributed By: (Distributed by:)

Advanced Rx

1942 NE 163rd St,

North Miami Beach, FL 33162 U.S.A.

*This product is not manufactured or distributed by the owner of the registered trademark Vicks ^®DayQuil ^®Cold & Flu LiquiCaps ^®

Other Information (Other information)

store at room temperature.
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, methyl paraben, propyl paraben, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 80513-303-50

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

50 Softgels

NON-DROWSY

DAYTIME

COLD & FLU RELIFE

Acetaminophen,

Phenylephrine HCl,

Dextromethorphan HBr

Pain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant

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

you get nervous, dizzy or sleepless
pain, nasal congestion or cough 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.

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
trouble urinating due to enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough as occurs with smoking, asthma, or emphysema

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

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever sore throat", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. 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 and for children even if you do not notice any signs or symptoms.", "50567-7": "When using this product, do not use more than directed.", "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.", "Purpose": "Pain reliever/fever reducer Cough suppressant Nasal decongestant", "Directions": "take only as directed do not exceed 4 doses per 24 hours adults and children 12 years and over take 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use", "Do not use": "with any other product containing acetaminophen (prescription or non-prescription). 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.", "Questions?": "1-800-630-8895", "Distributed by:": "Advanced Rx 1942 NE 163rd St, North Miami Beach, FL 33162 U.S.A. *This product is not manufactured or distributed by the owner of the registered trademark Vicks ® DayQuil ® Cold & Flu LiquiCaps ®", "Other information": "store at room temperature. DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.", "Inactive ingredients": "FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, methyl paraben, propyl paraben, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "NDC 80513-303-50 Compare to the active ingredients in Vicks ® DayQuil ® Cold & Flu LiquiCaps ® 50 Softgels NON-DROWSY DAYTIME COLD & FLU RELIFE Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr Pain Reliever Fever Reducer Cough Suppressant Nasal Decongestant", "Stop use and ask a doctor if": "you get nervous, dizzy or sleepless pain, nasal congestion or cough 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.", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema", "Active ingredients (in each softgel)": "Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:55.734014 · Updated: 2026-03-14T23:02:43.906306