Vicks® Dayquil™ Ultra Concentrated Cold & Flu, Liquicaps™

Vicks® Dayquil™ Ultra Concentrated Cold & Flu, Liquicaps™
SPL v10
SPL
SPL Set ID ff0a4054-0745-f649-e053-6394a90af904
Route
ORAL
Published
Effective Date 2023-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Water Sorbitol Glycerin Povidone Titanium Dioxide Mica Fd&c Yellow No. 5 Gelatin Fd&c Yellow No. 6 Lecithin, Soybean

Identifiers & Packaging

Pill Appearance
Imprint: DQ Shape: oval Color: orange Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-06

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine 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 Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion

• cough due to minor throat & bronchial irritation

• sore throat

• headache

• minor aches & pains • fever

Section 34088-5

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.

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Warnings

Liver warning:This product contains acetaminophen.

Severe liver damage may occur if you take

• more than 8 Liquicaps 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

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
  • take only as directed
  • do not exceed 8 LiquiCaps per 24 hrs
adults & children 12 yrs & over 2 LiquiCaps 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.

Questions?

1-800-362-1683

Other Information

store at no greater than 25°C

Inactive Ingredients

FD&C Yellow No. 5, FD&C Yellow No. 6, gelatin, glycerin, lecithin, mica, polyethylene glycol, polyvinyl acetate phthalate, povidone, sorbitol sorbitan solution, titanium dioxide, water

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 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 such as occurs with smoking, asthma, or emphysema

Active Ingredients (in Each Liquicap)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Principal Display Panel 48 Liquicaps™

MAX STRENGTH

100% MORE LIQUICAPS†

VICKS®

DayQuil™

ULTRA CONCENTRATED

COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

25% SMALLER*

EASY TO SWALLOW

48 LIQUICAPS™

Active Ingredients (in Each Liquicap) Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


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 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Warnings

Liver warning:This product contains acetaminophen.

Severe liver damage may occur if you take

• more than 8 Liquicaps 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

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
  • take only as directed
  • do not exceed 8 LiquiCaps per 24 hrs
adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

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.

Questions?

1-800-362-1683

Other Information (Other information)

store at no greater than 25°C

Inactive Ingredients

FD&C Yellow No. 5, FD&C Yellow No. 6, gelatin, glycerin, lecithin, mica, polyethylene glycol, polyvinyl acetate phthalate, povidone, sorbitol sorbitan solution, titanium dioxide, water

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 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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 such as occurs with smoking, asthma, or emphysema

Active Ingredients (in Each Liquicap) (Active ingredients (in each LiquiCap))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Principal Display Panel 48 Liquicaps™ (PRINCIPAL DISPLAY PANEL - 48 LiquiCaps™)

MAX STRENGTH

100% MORE LIQUICAPS†

VICKS®

DayQuil™

ULTRA CONCENTRATED

COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Cough

Non-Drowsy

25% SMALLER*

EASY TO SWALLOW

48 LIQUICAPS™

Active Ingredients (in Each Liquicap) Purpose (Active ingredients (in each LiquiCap) Purpose)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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


Raw Label Data

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