Valumeds Day Time Cold & Flu Multi-symptom Relief

SPL v7

SPL

SPL Set ID 07b2e805-e837-42a0-9d79-5cd06ea58506

Route

ORAL

Published

Effective Date 2018-04-18

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 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Titanium Dioxide Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance

Imprint: 512 Shape: capsule Color: orange Size: 21 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-04-18

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.

Section 50570-1

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.

Section 53414-9

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

Section 55105-1

Active ingredients (in each softgel)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan Hydrobromide 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 hours.

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

If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing

Liver Warning

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

more than 4 doses in 24 hours, which is the maximum daily amount for this product
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

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 and for children, even if you do not notice any signs or symptoms.

Other Information

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
this product does not contain phenylpropanolamine

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Sore Throat Warning:

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

Questions Or Comments?

1-888-333-9792

When Using This Product

do not use more than directed.

Stop Use and Ask A Doctor If

you get nervous, dizzy, or sleepless
pain, nasal congestion or cough gets 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 Softgels Blister Pack Carton

SEE NEW WARNINGS INFORMATION

COMPARE TO ACTIVE INGREDIENTS IN

VICKS ^® DAYQUIL ^®*

VALUMEDS ™

NON-DROWSY

DAY TIME

COLD & FLU MULTI-SYMPTOM RELIEF

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl

Pain Reliever

Fever Reducer
Cough Suppressant
Nasal Decongestant

48 SOFTGELS

Liquid filled capsules

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.

Section 50570-1 (50570-1)

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.

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)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan Hydrobromide 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 hours.

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

If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing

Liver Warning (Liver warning)

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

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

Allergy Alert: (Allergy alert:)

acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

Overdose Warning (Overdose warning)

Other Information (Other information)

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
this product does not contain phenylpropanolamine

Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Sore Throat Warning: (Sore throat warning:)

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

Questions Or Comments? (Questions or comments?)

1-888-333-9792

When Using This Product (When using this product)

do not use more than directed.

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 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 Softgels Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 48 Softgels Blister Pack Carton)

SEE NEW WARNINGS INFORMATION

COMPARE TO ACTIVE INGREDIENTS IN

VICKS ^® DAYQUIL ^®*

VALUMEDS ™

NON-DROWSY

DAY TIME

COLD & FLU MULTI-SYMPTOM RELIEF

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl

Pain Reliever

Fever Reducer
Cough Suppressant
Nasal Decongestant

48 SOFTGELS

Liquid filled capsules

Advanced Ingredient Data

[{"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.", "50570-1": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan Hydrobromide 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 hours. adults and children 12 years of age and over swallow 2 softgels with water every 4 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hours, which is the maximum daily amount for this product 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", "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 and for children, even if you do not notice any signs or symptoms.", "Other information": "store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat this product does not contain phenylpropanolamine", "Inactive ingredients": "FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide", "Sore throat warning:": "If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.", "Questions or comments?": "1-888-333-9792", "When using this product": "do not use more than directed.", "Stop use and ask a doctor if": "you get nervous, dizzy, or sleepless pain, nasal congestion or cough gets 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 Softgels Blister Pack Carton": "SEE NEW WARNINGS INFORMATION COMPARE TO ACTIVE INGREDIENTS IN VICKS ® DAYQUIL ® * VALUMEDS ™ NON-DROWSY DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl Pain Reliever Fever Reducer Cough Suppressant Nasal Decongestant 48 SOFTGELS Liquid filled capsules"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:46.891387 · Updated: 2026-03-14T23:05:42.419463