Vicks ®

Vicks ®
SPL v2
SPL
SPL Set ID 1b569c65-437c-1dbc-e063-6394a90a04aa
Route
ORAL
Published
Effective Date 2024-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Xanthan Gum Fd&c Yellow No. 6 Anhydrous Citric Acid Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sorbitol Sucralose Fd&c Blue No. 1 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-09

Description

VICKS ® DayQuil™ ELDERBERRY COLD & FLU Drug Facts

Purpose

Pain reliever/ fever reducer Cough suppressant


Medication Information

Purpose

Pain reliever/ fever reducer

Cough suppressant

Description

VICKS ® DayQuil™ ELDERBERRY COLD & FLU Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Section 34088-5

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.

Section 42229-5

VICKS ®DayQuil™ ELDERBERRY COLD & FLU

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

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.

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 

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.
Questions?

1-800-362-1683

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

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 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.

Active Ingredients (in Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

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
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)

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Section 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

VICKS ®DayQuil™ ELDERBERRY COLD & FLU

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/ fever reducer

Cough suppressant

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.

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 

Do Not Use (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.
Questions?

1-800-362-1683

Other Information (Other information)
  • each 15 mL contains: sodium 13 mg
  • store at no greater than 25°C and do not refrigerate
Inactive Ingredients (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

When Using This Product (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 (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.

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Ask A Doctor Before Use If You Have (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
Principal Display Panel Kit Carton (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)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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