vicks ® dayquil ® and vicks ® nyquil ® cold and flu multi

VICKS DAYQUIL AND VICKS NYQUIL COLD AND FLU MULTI-SYMPTOMRELIEF/COLD AND FLU NIGHTTIME RELIEF- acetaminophen, phenylephrinehydrochloride, dextromethorphan hydrobromide, and doxylamine succinate VICKS DAYQUIL AND VICKS NYQUIL COLD AND FLU MULTI-SYMPTOMRELIEF/COLD AND FLU NIGHTTIME RELIEF- acetaminophen, phenylephrinehydrochloride, dextromethorphan hydrobromide, acetaminophen, doxylaminesuccinate, and dextromethorphan hydrobromide The Procter & Gamble Manufacturing CompanyDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with applicable regulations and policies. FDA has notevaluated whether this product complies.

----------Vicks DayQuil and Vicks NyQuil

Cold and Flu Multi-Symptom Relief/Cold and Flu Nighttime ReliefDayQuil Cold & FluDrug Facts

Active ingredients (in eachLiquiCap) Purpose

Acetaminophen 325 mg Pain reliever/Feverreducer

Dextromethorphan HBr 10 mg Cough suppressantPhenylephrine HCl 5 mg Nasal decongestant

Usestemporarily relieves common cold/flu symptoms:

nasal congestioncough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfever

Warnings

Liver warningThis 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 productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

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Sore throat warningIf sore throat is severe, persists for more than 2 days, is accompanied or followed byfever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not usewith any other drug containing acetaminophen (prescription or nonprescription). Ifyou are not sure whether a drug contains acetaminophen, ask a doctor orpharmacist.if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certaindrugs for depression, psychiatric or emotional conditions, or Parkinson's disease), orfor 2 weeks after stopping the MAOI drug. If you do not know if your prescriptiondrug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you haveliver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to enlarged prostate glandcough that occurs with too much phlegm (mucus)persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drugwarfarin.When using this product, do not use more than directed.

Stop use and ask a doctor ifyou get nervous, dizzy or sleeplesspain, nasal congestion or cough get worse or last more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough 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.

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

Directionstake only as directed - see Overdose warning

do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 2 LiquiCaps with water every 4hrs

children 4 to under 12 yrs ask a doctorchildren under 4 yrs do not use

when using other DayQuil or NyQuil products, carefully read each labelto ensure correct dosing

Other informationstore at room temperature

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

Questions?1-800-251-3374NyQuil Cold & FluDrug Facts

Active ingredients (in eachLiquiCap) Purpose

Acetaminophen 325 mg Pain reliever/Feverreducer

Dextromethorphan HBr 15 mg Cough suppressantDoxylamine succinate 6.25 mg Antihistamine

Usestemporarily relieves common cold/flu symptoms:

cough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfeverrunny nose & sneezing

Warnings

Liver warning

®

Liver warningThis 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 productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

Sore throat warningIf sore throat is severe, persists for more than 2 days, is accompanied or followed byfever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not usewith any other drug containing acetaminophen (prescription or nonprescription). Ifyou are not sure whether a drug contains acetaminophen, ask a doctor orpharmacist.if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certaindrugs for depression, psychiatric or emotional conditions, or Parkinson's disease), orfor 2 weeks after stopping the MAOI drug. If you do not know if your prescriptiondrug contains an MAOI, ask a doctor or pharmacist before taking this product.to make a child sleep

Ask a doctor before use if you haveliver diseaseglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis or emphysematrouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizerstaking the blood thinning drug warfarin

When using this productdo not use more than directedexcitability may occur, especially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful when driving a motor vehicle or operating machineryalcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor ifpain or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough 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.

Overdose warningTaking more than the recommended dose can cause serious health problems. In case ofoverdose, get medical help or contact a Poison Control Center right away. Quick medicalattention is critical for adults as well as for children even if you do not notice any signsor symptoms.

Directionstake only as directed - see Overdose warningdo not exceed 4 doses per 24 hours

adults & children 12 yrs & over 2 LiquiCaps with water every 6hrs

children 4 to under 12 yrs ask a doctorchildren under 4 yrs do not use

when using other DayQuil or NyQuil products, carefully read each labelto ensure correct dosing

Other informationstore at room temperature

Inactive ingredientsD&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone,propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?1-800-362-1683Dist. by Procter & Gamble, Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 24 Capsule Kit Carton

COMBO PACKVICKS DayQuil

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®

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COLD & FLUMulti-Symptom Relief

Acetaminophen, Phenylephrine HCl,

Dextromethorphan HBrMinor Aches & Pains, Fever & Sore ThroatNasal CongestionCough

Non-Drowsy16 DayQuil LiquiCaps NyQuil COLD & FLUNighttime Relief

Acetaminophen, Doxylamine Succinate,

Dextromethorphan HBrMinor Aches & Pains, Fever & Sore ThroatSneezing, Runny NoseCough

8 NyQuil LiquiCaps : Total 24 Liquicaps ®

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®

®

PRINCIPAL DISPLAY PANEL - 48 Capsule Kit CartonGREAT

VALUE

COMBO PACKVICKS ®

DayQuil COLD & FLUMulti-Symptom ReliefAcetaminophen, Phenylephrine, Dextromethorphan

Aches, Fever & Sore ThroatNasal CongestionCough

Non-Drowsy32 DayQuil LiquiCapsNyQuil COLD & FLUNighttime ReliefAcetaminophen, Doxylamine, Dextromethorphan

Aches, Fever & Sore ThroatSneezing, Runny NoseCough

16 NyQuil LiquiCaps 48 Total

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®

®

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PRINCIPAL DISPLAY PANEL - 72 Capsule Kit CartonGREAT

VALUE

COMBO PACKVICKS DayQuilCOLD & FLUMulti-Symptom ReliefAcetaminophen, Phenylephrine HCl,

Dextromethorphan HBrAches, Fever & Sore ThroatNasal CongestionCough

Non-Drowsy

Alcohol Free / Antihistamine Free

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®

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48 DayQuil LiquiCapsNyQuilCOLD & FLUNighttime ReliefAcetaminophen, Doxylamine

Succinate, Dextromethorphan HBrAches, Fever & Sore ThroatSneezing, Runny NoseCough

24 NyQuil LiquiCaps 72 Total

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VICKS DAYQUIL AND VICKS NYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylaminesuccinate kit

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:37000-412

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:37000-412-24 1 in 1 PACKAGE 03/21/2014

Quantity of PartsPart # Package Quantity Total Product QuantityPart 1 8 BLISTER PACK 16 Part 2 4 BLISTER PACK 8

Part 1 of 2VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule,liquid filled

Product InformationRoute of Administration ORAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mgDEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHANHYDROBROMIDE 10 mg

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE -UNII:1WS297W6MV)

PHENYLEPHRINEHYDROCHLORIDE 5 mg

Inactive IngredientsIngredient Name Strength

FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product CharacteristicsColor orange Score no scoreShape OVAL Size 21mmFlavor Imprint Code DQuilContains

Packaging# Item

Code Package Description Marketing StartDate

Marketing EndDate

1 8 in 1 CARTON

1 2 in 1 BLISTER PACK; Type 0: Not a CombinationProduct

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph final part341 03/21/2014

Part 2 of 2VICKS NYQUIL COLD AND FLU NIGHTTIME RELIEF acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

Product InformationItem Code (Source) NDC:37000-557

Route of Administration ORAL




DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE -UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg


POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product CharacteristicsColor green Score no scoreShape OVAL Size 21mmFlavor Imprint Code NQUILContains

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:37000-557-

08 4 in 1 CARTON




Marketing StartDate

Marketing EndDate




Marketing StartDate

Marketing EndDate


VICKS DAYQUIL AND VICKS NYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, acetaminophen,doxylamine succinate, and dextromethorphan hydrobromide kit




Part 1 of 2VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule,liquid filled










Packaging# Item


Marketing EndDate

1 16 in 1 CARTON




Marketing StartDate

Marketing EndDate









D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product CharacteristicsColor green Score no score

Shape OVAL Size 21mmFlavor Imprint Code NQUILContains

Packaging# Item


Marketing EndDate

1 8 in 1 CARTON




Marketing StartDate

Marketing EndDate




Marketing StartDate

Marketing EndDate


VICKS DAYQUIL AND VICKS NYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, acetaminophen,doxylamine succinate, and dextromethorphan hydrobromide kit




Part 1 of 2

VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule,liquid filled











Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:37000-558-

48 24 in 1 CARTON




Marketing StartDate

Marketing EndDate










D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product CharacteristicsColor green Score no scoreShape OVAL Size 21mmFlavor Imprint Code NQUILContains

PackagingMarketing Start Marketing End

The Procter & Gamble Manufacturing Company

# Item Code Package Description Marketing StartDate

Marketing EndDate

1 NDC:37000-557-24 12 in 1 CARTON




Marketing StartDate

Marketing EndDate




Marketing StartDate

Marketing EndDate


Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 11/2021

vicks ® dayquil ® and vicks ® nyquil ® cold and flu multi

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