Vicks ® DayQuil ® and Vicks ® NyQuil ® Severe Cold and Flu

VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU- acetaminophen,phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate andguaifenes in The Procter & Gamble Manufacturing CompanyDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vicks DayQuil and Vicks NyQuil

Severe Cold and FluDayQuil SEVERE COLD & FLUDrug Facts

Active ingredients (in each caplet) PurposeAcetaminophen 325 mg Pain reliever/fever reducerDextromethorphan HBr 10 mg Cough suppressantGuaifenesin 200 mg ExpectorantPhenylephrine HCl 5 mg Nasal decongestant

Usestemporarily relieves common cold/flu symptoms:

nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationminor aches & painsheadachefeversore throatreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainagehelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways ofbothersome mucus and make coughs more productive.

Warnings

Liver warningThis product contains acetaminophen.

Severe liver damage may occur if you takemore 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 by fever, headache,rash, nausea, or vomiting, consult a doctor promptly.

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Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not surewhether a drug contains acetaminophen, ask a doctor or pharmacist.if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fordepression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks afterstopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask adoctor 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, chronic bronchitis, or emphysema

Ask a doctor or pharmacis t before use if you are taking the blood thinning drug warfarin.

When us ing this product, do not use more than directed.

Stop use and ask a doctor ifyou get nervous, dizzy or sleeplesspain, nasal congestion, 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 breas t-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, get medical help orcontact a Poison Control Center right away. Quick medical attention is critical for adults as well as forchildren even if you do not notice any signs or symptoms.

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

adults & children 12 yrs & over 2 caplets with water every 4 hrschildren 4 to under 12 yrs ask a doctorchildren under 4 yrs do not use

when us ing other DayQuil or NyQuil products , carefully read each label to ensure correctdos ing

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Other informationeach caplet contains : sodium 4 mgstore at room temperature

Inactive ingredientscroscarmellose sodium, crospovidone, FD&C Yellow No. 6, maltodextrin, mica, microcrystallinecellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch,silicon dioxide, stearic acid, talc, titanium dioxide

Questions?1-800-251-3374NyQuil SEVERE COLD & FLUDrug Facts

Active ingredients (in each caplet) PurposeAcetaminophen 325 mg Pain reliever/fever reducerDextromethorphan HBr 10 mg Cough suppressantDoxylamine succinate 6.25 mg AntihistaminePhenylephrine HCl 5 mg Nasal decongestant

Usestemporarily relieves common cold/flu symptoms:

nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationcough to help you sleepminor aches & painsheadachefeversore throatrunny nose & sneezingreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainage

Warnings

Liver warningThis product contains acetaminophen.

Severe liver damage may occur if you takemore than 4 doses in 24 hours, 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 by fever, headache,

rash, nausea, or vomiting, consult a doctor promptly.

Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not surewhether a drug contains acetaminophen, ask a doctor or pharmacist.if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fordepression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks afterstopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask adoctor or pharmacist before taking this product.to make a child sleep

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

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

When us ing 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, and tranquilizers may increase drowsiness

Stop use and ask a doctor ifyou get nervous, dizzy or sleeplesspain, nasal congestion, 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 breas t-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, get medical help orcontact a Poison Control Center right away. Quick medical attention is critical for adults as well as forchildren even if you do not notice any signs or symptoms.

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

adults & children 12 yrs & over 2 caplets with water every 4 hrschildren 4 to under 12 yrs ask a doctorchildren under 4 yrs do not use

when us ing other DayQuil or NyQuil products , carefully read each label to ensure correctdos ing

Other informationstore at room temperature

Inactive ingredientscrospovidone, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, magnesium stearate,mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone,pregelatinized starch, stearic acid, talc, titanium dioxide

Questions?1-800-362-1683DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 24 Caplet Kit CartonMAX STRENGTH VICKS DayQuil SEVERE

COLD & FLUAcetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin

Headache, Fever, Sore Throat, Minor Aches & PainsNasal/Sinus Congestion & Sinus PressureCoughChest Congestion

Non-Drowsy16 DAYQUIL SEVERE CAPLETS;NyQuil SEVERE

COLD & FLU

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Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & PainsNasal/Sinus Congestion & Sinus PressureSneezing, Runny NoseCough

Nighttime Relief8 NYQUIL SEVERE CAPLETS; TOTAL 24 CAPLETS




Non-Drowsy32 DAYQUIL SEVERE CAPLETS;NyQuil SEVERE

COLD & FLUAcetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr



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Non-Drowsy

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48 DAYQUIL SEVERE CAPLETS;NyQuil SEVERE

COLD & FLUAcetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr



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VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate andguaifenesin kit

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:370 0 0 -416

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:370 0 0 -416 -48 1 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 0 7/21/20 14

Quantity of PartsPart # Package Quantity Total Product Quantity

Pa rt 1 16 BLISTER PACK 32


Part 1 of 2

VICKS DAYQUIL SEVERE COLD AND FLU acetaminophen, phenylephrine hydrochloride, guiafenesin and dextromethorphan hydrobromide tablet

Product InformationRoute of Adminis tration ORAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 325 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHANHYDROBROMIDE 10 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -UNII:1WS29 7W6 MV)

PHENYLEPHRINEHYDROCHLORIDE 5 mg

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ) GUAIFENESIN 20 0 mg

Inactive IngredientsIngredient Name Strength

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

MICA (UNII: V8 A1AW0 8 8 0 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product CharacteristicsColor o range Score no sco re

Shape OVAL Siz e 19 mm

Flavor Imprint Code DQ

Contains

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 16 in 1 CARTON

1 2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part341 0 7/21/20 14

Part 2 of 2

VICKS NYQUIL SEVERE COLD AND FLU acetaminophen, doxylamine succinate, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet,coated






DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL) DOXYLAMINE SUCCINATE 6 .25 mg





D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)


MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )










Product CharacteristicsColor green Score no sco re


Flavor Imprint Code NQ

Contains









Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:370 0 0 -417-72 1 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 0 7/21/20 14

Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 24 BLISTER PACK 48


Part 1 of 2




























Contains





Part 2 of 2




























Contains









Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:370 0 0 -415-24 1 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 0 7/21/20 14

Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 8 BLISTER PACK 16


Part 1 of 2




























Contains





Part 2 of 2




























Contains

Packaging

The Procter & Gamble Manufacturing Company

# Item Code Package Description Marketing Start Date Marketing End Date1 4 in 1 CARTON






Labeler - T he Procter & Gamble Manufacturing Company (004238200)

Revised: 1/2020

Vicks ® DayQuil ® and Vicks ® NyQuil ® Severe Cold and Flu

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