non drowsy daytime cold and flu softgel - 48ct

SPL v2

SPL

SPL Set ID f6e1438d-f2a0-49ee-8c96-c8ff2b70b642

Route

oral

Published

Effective Date 2022-01-07

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 red no. 40 fd&c yellow no. 6 gelatin, unspecified glycerin polyethylene glycol, unspecified povidone, unspecified propylene glycol water titanium dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 786 Shape: oval Color: orange Size: 20 mm Score: 1

Marketing Status

otc monograph final active Since 2021-05-01

Description

Drug Facts

Medication Information

Uses

temporarily relieves common cold/flu symptoms:

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

Directions

take only as directed - see Overdose warning
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	2 softgels with water every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other Information

store at room temperature between 20-25 °C (68-77 °F)

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if you are taking 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 Softgel)	Purposes
Acetaminophen 325 mg	Pain reliever / Fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

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.

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.

Liver Warning

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

more than 4 doses in 24 hrs, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Sore Throat Warning

If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Questions Or Comments

1-800-632-6900

Stop Use and Ask A Doctor If

you get nervous, dizzy or sleepless
pain, nasal congestion or cough get worse or last 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
thyroid disease
diabetes
high blood pressure
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

Principal Display Panel 48 Softgel Blister Pack Carton

COMPARE TO the active ingredients of VICKS^® DAYQUIL™

COLD & FLU RELIEF LIQUICAPS™ *See bottom panel

NDC 30142-768-48

POWERFUL

NON-DROWSY

RELIEF

Kroger_®

OUR PHARMACIST RECOMMENDED

Cold & Flu

DayTime

Multi-Symptom Relief

Acetaminophen

Dextromethorphan HBr

Phenylephrine HCl

actual

size

Pain Reliever

Fever Reducer

Cough Suppressant

Nasal Decongestant

48 SOFTGELS

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

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

Directions

take only as directed - see Overdose warning
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	2 softgels with water every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other Information (Other information)

store at room temperature between 20-25 °C (68-77 °F)

Inactive Ingredients (Inactive ingredients)

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 you are taking 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 Softgel)	Purposes
Acetaminophen 325 mg	Pain reliever / Fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

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.

Allergy Alert (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.

Liver Warning (Liver warning)

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

more than 4 doses in 24 hrs, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Overdose Warning (Overdose warning)

Sore Throat Warning (Sore throat warning)

If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Questions Or Comments (Questions or comments)

1-800-632-6900

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 get worse or last 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
thyroid disease
diabetes
high blood pressure
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

Principal Display Panel 48 Softgel Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 48 Softgel Blister Pack Carton)

COMPARE TO the active ingredients of VICKS^® DAYQUIL™

COLD & FLU RELIEF LIQUICAPS™ *See bottom panel

NDC 30142-768-48

POWERFUL

NON-DROWSY

RELIEF

Kroger_®

OUR PHARMACIST RECOMMENDED

Cold & Flu

DayTime

Multi-Symptom Relief

Acetaminophen

Dextromethorphan HBr

Phenylephrine HCl

actual

size

Pain Reliever

Fever Reducer

Cough Suppressant

Nasal Decongestant

48 SOFTGELS

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 & bronchial irritation sore throat headache minor aches & pains fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "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.", "55105-1": "Active ingredients (in each Softgel) Purposes Acetaminophen 325 mg Pain reliever / Fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant", "Directions": "take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs 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.", "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.", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product", "Overdose warning": "Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.", "Other information": "store at room temperature between 20-25 °C (68-77 °F)", "Sore throat warning": "If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Inactive ingredients": "FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide", "Questions or comments": "1-800-632-6900", "Stop use and ask a doctor if": "you get nervous, dizzy or sleepless pain, nasal congestion or cough get worse or last 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 thyroid disease diabetes high blood pressure 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", "PRINCIPAL DISPLAY PANEL - 48 Softgel Blister Pack Carton": "COMPARE TO the active ingredients of VICKS ® DAYQUIL™ COLD & FLU RELIEF LIQUICAPS™ *See bottom panel NDC 30142-768-48 POWERFUL NON-DROWSY RELIEF Kroger ® OUR PHARMACIST RECOMMENDED Cold & Flu DayTime Multi-Symptom Relief Acetaminophen Dextromethorphan HBr Phenylephrine HCl actual size Pain Reliever Fever Reducer Cough Suppressant Nasal Decongestant 48 SOFTGELS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:57.270829 · Updated: 2026-03-14T23:00:12.227844