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

DayQuil Cold & Flu

Drug Facts

ACTIVE INGREDIENT

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant

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 you take

• more than 8 LiquiCaps 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
• 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 are taking 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 get worse or last 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 & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed
• do not exceed 4 doses per 24 hrs

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

Other information

• store at room temperature

Inactive ingredients

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

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

NyQuil Cold & Flu

Drug Facts

ACTIVE INGREDIENT

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Pain reliever/Fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation
• 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 8 LiquiCaps 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.
• 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.

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
• do not exceed 4 doses per 24 hours

adults & children 12 yrs & over 2 LiquiCaps with water every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other information

• store at room temperature

Inactive ingredients

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

Questions?

1-800-362-1683

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 12 Capsule 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

Non-Drowsy

8 DayQuil LiquiCaps

NyQuil™

COLD & FLU

Nighttime Relief

Acetaminophen, Doxylamine Succinate,
Dextromethorphan HBr

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

4 NyQuil LiquiCaps: 12 Total Liquicaps

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-933

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-933-12	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	07/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	8
Part 2	1 BLISTER PACK	4

Part 1 of 2

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

Product Information
Item Code (Source)	NDC: 37000-558
Route of Administration	ORAL

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

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

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	DQuil
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 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 final	part341	03/21/2014

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 37000-557
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

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

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	NQUIL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 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 final	part341	03/21/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)