VICKS DAYQUIL AND VICKS NYQUIL ELDERBERRY COLD AND FLU- acetaminophen, dextromethorphan hbr, 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, Novacyl Wuxi Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

VICKS ®DayQuil™ ELDERBERRY COLD & FLU

Drug Facts

Active ingredients (in each 15 mL)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg

Purpose

Pain reliever/ fever reducer
Cough suppressant

Uses

temporarily relieves common cold/flu symptoms:

• 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

• adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
• child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
• taken 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
• glaucoma
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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 gets worse or lasts more than 5 days (children) or 7 days (adults)
• 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.

PREGNANCY OR BREAST FEEDING

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 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 13 mg
• store at no greater than 25°C and do not refrigerate

Inactive ingredients

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor (with elderberry), glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, water, xanthan gum

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® NyQuil™ ELDERBERRY COLD & FLU

Drug Facts

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Purpose

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

• adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
• child takes more than 4 doses (15 mL eah) in 24 hrs, which is the maximum daily amount for this product
• taken 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
• 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

• excitability may occur, especially in children
• marked dowsiness 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 get worse or lasts more than 5 days (children) or 7 days (adults)
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.

PREGNANCY OR BREAST FEEDING

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 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 13 mg
store at no greater than 25⁰C  and do not refrigerate

Inactive ingredients

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor (with elderberry), glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, water, xanthan gum

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 - Kit Carton

POWERFUL RELIEF

BLACK ELDERBERRY FLAVORED

Vicks DayQuil and NyQuil ELDERBERRY

COLD & FLU

Vicks DayQuil ELDERBERRY

COLD & FLU

THE DAYTIME, COUGHING, ACHING, SORE THROAT, FEVER, POWER THROUGH YOUR DAY, MEDICINE.

Acetaminophen, Dextromethorphan HBr

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

Vicks NyQuil ELDERBERRY

COLD & FLU

THE NIGHTTIME, SNIFFLING, SNEEZING, COUGHING, ACHING, FEVER, BEST SLEEP WITH A COLD, MEDICINE.

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate

Headache, Fever, Sore Throat, minor Aches & Pains

Sneezing, Runny Nose

Cough

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

INGREDIENTS AND APPEARANCE

VICKS DAYQUIL AND VICKS NYQUIL  ELDERBERRY COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-309

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-309-24	1 in 1 PACKAGE; Type 0: Not a Combination Product	07/09/2024

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  ELDERBERRY COLD AND FLU
acetaminophen, dextromethorphan hbr liquid

Product Information
Item Code (Source)	NDC: 84126-307
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-307-12	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	07/09/2024

Part 2 of 2

VICKS NYQUIL  ELDERBERRY COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Item Code (Source)	NDC: 84126-308
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-308-12	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	07/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/09/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
Novacyl Wuxi Pharmaceutical Co., Ltd.		263624659	api manufacture(84126-308)