Vicks Dayquil-d Nyquil-d Kit
FDA Label NDC 84126-365

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Dayquil-d Nyquil-d (NDC 84126-365). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each liquicap), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each Liquicap)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product do Not Use More Than Directed

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Overdosage

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Principal Display Panel

Other

Vicks ^®DayQuil-D™ Cold & Sinus + Severe Congestion, Liquicaps

Drug Facts

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

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

Vicks ^®NyQuil-D™ Cold & Sinus + Severe Congestion, Liquicaps

Drug Facts

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

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

Active Ingredient (In Each Liquicap)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Pseudoephedrine HCl 30 mg

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Pseudoephedrine HCl 30 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion
sinus congestion & pressure
cough due to minor throat & bronchial irritation
minor aches & pains
headache
fever
sore throat
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

temporarily relieves common cold/flu symptoms:

nasal congestion
sinus congestion & pressure
cough due to minor throat & bronchial irritation
cough to help you sleep • minor aches & pains
headache
fever
sore throat
runny nose & sneezing
reduces swelling of nasal passages
temporarily
restores freer breathing through the nose
promotes nasal and/or sinus drainage

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.

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.

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.

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.

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

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

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.

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.

Keep Out Of Reach Of Children.

Overdosage

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.

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 under 12 yrs	do not use

take only as directed
do not exceed 6 LiquiCaps per 24 hrs

adults & children 12 yrs & over	2 LiquiCaps with water every 6 hrs
children under 12 yrs	do not use

Other Information

store at no greater than 25°C (77°F)

store at no greater than 25°C (77°F)

Inactive Ingredients

1,4-Sorbitan, alcohol, ammonia, ethyl acetate, FD&C Yellow No. 5, FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, mannitol, mica, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, sorbitol, titanium dioxide, water

1,4-Sorbitan, alcohol, ammonia, D&C Yellow No. 10, ethyl acetate, FD&C Blue No. 1, gelatin, glycerin, Isopropyl alcohol, mannitol, mica, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, sorbitol, titanium dioxide, water

Questions?

1-800-362-1683

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When Using This Product

do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

Principal Display Panel

POWERFUL RELIEF

VALUE PACK

VICKS®

DayQuil-D

COLD & SINUS

+ SEVERE CONGESTION

Acetaminophen, Guaifenesin, Pseudoephedrine HCl, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Chest Congestion, Thins & Loosens Mucus

Nasal Congestion, Sinus Pressure

Cough

Daytime Relief

12 LIQUICAPS™

VICKS®

NyQuil-D

COLD & SINUS

+ SEVERE CONGESTION

Acetaminophen, Pseudoephedrine HCl, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Sneezing, Runny Nose

Cough

Nighttime Relief

12 LIQUICAPS™

12 DAYQUIL-D LIQUICAPS™ 12 NYQUIL-D LIQUICAPS™ 24 TOTAL LIQUICAPS™

365 (365)

* Please review the disclaimer below.

Previous Product 84126-364

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Structured Product Label

Label Section Quick Index

Other

Active Ingredient (In Each Liquicap)

Purpose

Uses

Warnings

Do Not Use

Ask A Doctor Before Use If You Have

﻿Ask A Doctor Or Pharmacist Before Use If You Are

When Using This Product Do Not Use More Than Directed

Stop Use And Ask A Doctor If

If Pregnant Or Breast-Feeding,

Keep Out Of Reach Of Children.

Overdosage

Directions

Other Information

Inactive Ingredients

Questions?

Ask A Doctor Or Pharmacist Before Use If You Are

When Using This Product

Principal Display Panel

Ask A Doctor Or Pharmacist Before Use If You Are