vicks ®

vicks ®
SPL v6
SPL
SPL Set ID 32819305-9bbd-8843-e063-6294a90a7f2e
Route
oral
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) doxylamine (6.25 mg) dextromethorphan (10 mg)
Inactive Ingredients
silicon dioxide crospovidone d&c yellow no. 10 aluminum lake magnesium stearate polyethylene glycol fd&c blue no. 2 aluminum lake microcrystalline cellulose starch, corn fd&c yellow no. 6 aluminum lake polyvinyl alcohol povidone stearic acid talc titanium dioxide sucralose

Identifiers & Packaging

Pill Appearance
Imprint: NQV Shape: oval Color: green Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-05-06

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Description

Drug Facts


Medication Information

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 8 caplets 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
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
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions
  • take only as directed
  • do not exceed 8 caplets per 24 hrs
adults & children 12 yrs & over 2 caplets 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 no greater than 25ºC (77°F)
Inactive Ingredients

corn starch, crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow # 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Description

Drug Facts

Questions?

1-800-362-1683

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

Drug Facts

Section 50565-1

Keep out of reach of children.

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.
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.

When Using This Product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
  • 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.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

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
Principal Display Panel 24 Coated Caplets

VICKS ® NyQuil™ VapoCOOL™ COLD & FLU

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

•Headache, Fever, Sore Throat, Minor Aches & Pains

•Sneezing, Runny Nose

•Cough

Nighttime Relief

24 COATED CAPLETS

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 8 caplets 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
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
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions
  • take only as directed
  • do not exceed 8 caplets per 24 hrs
adults & children 12 yrs & over 2 caplets with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other Information (Other information)
  • store at no greater than 25ºC (77°F)
Inactive Ingredients (Inactive ingredients)

corn starch, crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow # 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions?

1-800-362-1683

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)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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.
Sore Throat Warning (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.

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 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)
  • 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
Principal Display Panel 24 Coated Caplets (PRINCIPAL DISPLAY PANEL - 24 COATED CAPLETS)

VICKS ® NyQuil™ VapoCOOL™ COLD & FLU

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

•Headache, Fever, Sore Throat, Minor Aches & Pains

•Sneezing, Runny Nose

•Cough

Nighttime Relief

24 COATED CAPLETS

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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