Vicks DayQuil and Vicks NyQuil Cherry Cold and Flu: Package Insert and Label Information

VICKS DAYQUIL AND VICKS NYQUIL CHERRY COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

NyQuil Cold & Flu

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

Pain reliever/ fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation
• sore throat
• nasal congestion
• headache
• minor aches & pains
• fever
• runny nose and sneezing

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4 doses 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
• 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
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• 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

Stop use and ask a doctor if

• pain 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.

Overdose warning

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
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 30 mL every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other information

• each 30 mL tablespoon contains: potassium 5 mg, sodium 38 mg
• store at room temperature and do not refrigerate

Inactive ingredients

acesulfame potassium, alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup,
polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions?

1-800-362-1683

Dist. by Procter & Gamble, Cincinnati OH 45202

DayQuil Cold & Flu

Drug Facts

Active ingredients (in each 15 mL)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Nasal decongestan

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

• adults take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
• child take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• adult has 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, or emphysema
• a sodium-restricted diet
• 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.

Overdose warning

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
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 30 mL every 4 hrs
children 6 to under 12 yrs 15 mL every 4 hrs
children 4 to under 6 yrs ask a doctor
children under 4 yrs do not use

Other information

• each 15 mL contains: sodium 46 mg
• store at room temperature and do not refrigerate.

Inactive ingredients

citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate,
sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-800-362-1683

Dist. by Proctor & Gamble, Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL — Kit Carton

POWERFUL

RELIEF

Day or Night

VICKS ^®

DayQuil ™

COLD & FLU

Multi-Symptom Relief

Acetaminophen , Phenylephrine HCl, Dextromethorphan HBr,

• Headache, Fever, Sore Throat,
  Minor Aches & Pains
• Nasal Congestion
• Cough

NyQuil ™

COLD & FLU

Nighttime Relief

Acetaminophen , Doxylamine

Succinate, Dextromethorphan HBr

• Headache, Fever, Sore Throat Minor Aches & Pains
• Sneezing, Runny Nose
• Cough

Alcohol 10%

TWO 12 FL OZ (354 ml) BOTTLES

TOTAL 24 FL OZ (708 ml)

VICKS DAYQUIL AND VICKS NYQUIL CHERRY COLD AND FLU acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-031

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37000-031-24 1 KIT in 1 PACKAGE None 2 NDC:37000-031-12 1 KIT in 1 PACKAGE None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 354 mL Part 2 1 BOTTLE, PLASTIC 354 mL

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

Product Information Item Code (Source) NDC:37000-555 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SORBITOL SUCRALOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

Product Characteristics Color orange Score Shape Size Flavor APRICOT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37000-555-12 354 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/22/2011

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

Product Information Item Code (Source) NDC:37000-808 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL

Inactive Ingredients Ingredient Name Strength HIGH FRUCTOSE CORN SYRUP ALCOHOL PEG-40 STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM

Product Characteristics Color red Score Shape Size Flavor CHERRY, MENTHOL Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37000-808-12 354 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2010

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M012 07/01/2013

Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 01/2023 The Procter & Gamble Manufacturing Company