VICKS DAYQUIL AND VICKS NYQUIL INTENSE FLU- acetaminophen, dextromethorphan hbr kit

Vicks DayQuil and Vicks NyQuil by

Drug Labeling and Warnings

Vicks DayQuil and Vicks NyQuil by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Vicks ® NyQuil™ INTENSE FLU MULTI-SYMPTOM Liquid

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/ fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation
• cough to help you sleep
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take
more than 3 doses (30 mL each) in 24 hrs, 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.

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

• 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

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

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
• 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 contains: sodium 24 mg
• store at no greater than 25°C and do not refrigerate

Inactive ingredients

alcohol, anhydrous citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, water

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND ON BOTTLE IS BROKEN OR MISSING.

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

SPL UNCLASSIFIED SECTION

Vicks ® DayQuil™ INTENSE FLU MULTI-SYMPTOM Liquid

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 1000 mg
Dextromethorphan HBr 30 mg

Purpose

Pain reliever/fever reducer
Cough suppressant

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take
more than 3 doses (30 mL each) in 24 hrs, 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
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain or cough get 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

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
• only use the dose cup provided
• do not exceed 3 doses (30 mL each) per day (24 hrs)

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

Other information

• each 30 mL contains: sodium 24 mg
• store at no greater than 25ºC (77ºF) and do not refrigerate

Inactive ingredients

alcohol, anhydrous citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, water

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND ON BOTTLE IS BROKEN OR MISSING.

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Convenience Pack

VALUE PACK

VICKS ® DayQuil™ INTENSE FLU

MULTI-SYMPTOM

Acetaminophen, Dextromethorphan HBr

Pain reliever/Fever reducer, Cough suppressant

BODY ACHES

FEVER

HEADACHE

SORE THROAT

COUGH

Daytime Relief

Alcohol 10%

VICKS ® NyQuil ™ INTENSE FLU

MULTI-SYMPTOM

Acetaminophen- Pain reliever/fever reducer

Doxylamine Succinate - Antihistamine

Dextromethorphan HBr - Cough suppressant

BODY ACHES

FEVER

HEADACHE

SORE THROAT

SNEEZING

RUNNY NOSE

COUGH

Nighttime Relief

Alcohol 10%

2 BOTTLES - 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)

INGREDIENTS AND APPEARANCE

VICKS DAYQUIL AND VICKS NYQUIL  INTENSE FLU
acetaminophen, dextromethorphan hbr kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-358

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-358-24	1 in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2025

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  INTENSE FLU
acetaminophen, dextromethorphan hbr liquid

Product Information
Item Code (Source)	NDC: 84126-356
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	1000 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY (Black Cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-356-12	354 mL in 1 BOTTLE, PLASTIC; 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	07/01/2025

Part 2 of 2

VICKS NYQUIL  INTENSE FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Item Code (Source)	NDC: 84126-357
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	1000 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY (Black Cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-357-12	354 mL in 1 BOTTLE, PLASTIC; 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	07/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2025

Labeler - The Procter & Gamble Manufacturing Company (004238200)