DAYQUIL AND NYQUIL SEVERE PLUS VICKS VAPOCOOL COLD ...

DAYQUIL AND NYQUIL SEVERE PLUS VICKS VAPOCOOL COLD AND FLU- acetaminophen, phenylephrine hydrochloride, and doxylamine succinate  The Procter & Gamble Manufacturing Company

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DayQuil & Nyquil Severe + Vicks VapoCool Cold & Flu Caplets 48 ct Convenience Pack

DayQuil SEVERE + Vicks® VapoCool™ Cold & Flu

Active ingredients (in each caplet)

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant 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

Warnings

Liver warning:

This product contains acetaminophen.

Severe liver damage may occur if you take

• more than 8 caplets 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.

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, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you aretaking 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.

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

Keep out of reach of children.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 caplets per 24 hrs

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

Other information

each caplet contains:

• sodium 4 mg
• do not exceed 25°C

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C Yellow No. 6 Aluminum Lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions?

1-800-362-1683

NyQuil™ SEVERE + Vicks® VapoCool™ Cold & Flu

Active ingredients (in each caplet)

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Purpose

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
• 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 caplets 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.
• to make a child sleep

Ask a doctor before use if you have

• 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 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 & tranquilizers may increase drowsiness

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.

Keep out of reach of children.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 caplets per 24 hrs

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

Other information

• do not exceed 25°C

Inactive ingredients

crospovidone, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions?

1-800-362-1683

DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202.

PRINCIPAL DISPLAY PANEL - Kit Carton

DayQuil™

SEVERE +

VICKS® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin

Minor Aches & Pains, Fever Nasal Congestion & Sinus Pressure Cough Chest Congestion

Non-Drowsy

32 DAYQUIL COATED CAPLETS

NyQuil™

SEVERE +

VICKS® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr

Minor Aches & Pains, Fever Nasal Congestion & Sinus Pressure Sneezing, Runny Nose Cough

Nighttime Relief

16 NYQUIL COATED CAPLETS; 48 TOTAL COATED CAPLETS

DAYQUIL AND NYQUIL SEVERE PLUS VICKS VAPOCOOL  COLD AND FLU acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-534

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-534-48 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 08/01/2018 03/22/2023

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 BLISTER PACK 32  Part 2 8 BLISTER PACK 16

Part 1 of 2 DAYQUIL SEVERE PLUS VICKS VAPOCOOL  COLD AND FLU acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet

Product Information Item Code (Source) NDC:37000-524 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)   FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)   POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)   FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)   FD&C YELLOW NO. 6 (UNII: H77VEI93A8)   ALUMINUM OXIDE (UNII: LMI26O6933)   MAGNESIUM STEARATE (UNII: 70097M6I30)   CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)   POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)   POVIDONE (UNII: FZ989GH94E)   SILICON DIOXIDE (UNII: ETJ7Z6XBU4)   TITANIUM DIOXIDE (UNII: 15FIX9V2JP)   STEARIC ACID (UNII: 4ELV7Z65AP)   CROSPOVIDONE (UNII: 2S7830E561)   TALC (UNII: 7SEV7J4R1U)   SUCRALOSE (UNII: 96K6UQ3ZD4)   STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics Color orange Score no score Shape OVAL Size 19mm Flavor Imprint Code DQ Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/01/2018 03/22/2024

Part 2 of 2 NYQUIL SEVERE PLUS VICKS VAPOCOOL  COLD AND FLU acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide tablet, coated

Product Information Item Code (Source) NDC:37000-523 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)   FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)   MAGNESIUM STEARATE (UNII: 70097M6I30)   POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)   POVIDONE (UNII: FZ989GH94E)   CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)   FD&C YELLOW NO. 6 (UNII: H77VEI93A8)   ALUMINUM OXIDE (UNII: LMI26O6933)   TITANIUM DIOXIDE (UNII: 15FIX9V2JP)   POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)   TALC (UNII: 7SEV7J4R1U)   CROSPOVIDONE (UNII: 2S7830E561)   STEARIC ACID (UNII: 4ELV7Z65AP)   D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)   SUCRALOSE (UNII: 96K6UQ3ZD4)   STARCH, CORN (UNII: O8232NY3SJ)   SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics Color green Score no score Shape OVAL Size 19mm Flavor Imprint Code NQ Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/01/2018 03/22/2024

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/01/2018 03/22/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2023 Document Id: 0c6bba5b-74cb-f67c-e063-6294a90ac024 34390-5 Set id: 72c562d9-f5b2-c3cd-e053-2a91aa0ad648 Version: 10 Effective Time: 20231213  The Procter & Gamble Manufacturing Company