Nyquil ™

Nyquil ™
SPL v1
SPL
SPL Set ID 37c768f5-dabd-22d0-e063-6394a90af9e5
Route
ORAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (6.25 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Povidone, Unspecified Stearic Acid Sucralose Talc D&c Yellow No. 10 Aluminum Lake Magnesium Stearate Polyvinyl Alcohol, Unspecified Polyethylene Glycol, Unspecified Fd&c Blue No. 2 Aluminum Lake Silicon Dioxide Microcrystalline Cellulose Titanium Dioxide Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: NQV Shape: oval Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Purpose

​Purpose Pain reliever/fever red Cough suppressant Antihistamine


Medication Information

Purpose

​Purpose

Pain reliever/fever red

Cough suppressant

Antihistamine

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Uses

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
Directions

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

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.

Nyquil ™

VICKS

NyQuil

COLD & FLU

Acetaminophen, Docylamine

Succinate, Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

VapoCOOL

COATED

4 Coated Caplets

[Lil' Drug Store ® logo]

Questions?

Questions? 1-800-362-1683

Allergy Alert

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

​liver Warning

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
Other Information

Other information

  • store at no greater than 25°C (77°F)
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.

Inactive Ingredients

Inactive ingredients

corn starch, 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

​active Ingredients

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Before Use

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
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

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

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

Keep Out of Reach of Children

Keep out of reach of children. 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.

Ask A Doctor Or Pharmacist Before Use

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Nyquil Cold & Flu W/vapocool, 4ct (pe Free), Cvp ®

VICKS

NyQuil™

COLD & FLU

Acetaminophen, Docylamine

Succinate, Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

VapoCOOL

COATED

4 Coated Caplets

[CVP ® HEALTH logo]

Nyquil Cold & Flu W/vapocool, 4ct (pe Free), Travel Basix

VICKS

NyQuil™

COLD & FLU

Acetaminophen, Docylamine

Succinate, Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

VapoCOOL

COATED

4 Coated Caplets

[Travel BASIX logo]


Structured Label Content

Uses

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

​Purpose

Pain reliever/fever red

Cough suppressant

Antihistamine

Directions

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

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.

Nyquil ™ (NyQuil ™)

VICKS

NyQuil

COLD & FLU

Acetaminophen, Docylamine

Succinate, Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

VapoCOOL

COATED

4 Coated Caplets

[Lil' Drug Store ® logo]

Questions?

Questions? 1-800-362-1683

Allergy Alert

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

​liver Warning (​Liver warning)

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
Other Information (Other information)

Other information

  • store at no greater than 25°C (77°F)
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

corn starch, 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

​active Ingredients (​Active ingredients)

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Before Use (Ask a doctor before use)

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
When Using This Product (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 (Stop use and ask a doctor)

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 (If pregnant 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)

Keep out of reach of children. 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.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Nyquil Cold & Flu W/vapocool, 4ct (pe Free), Cvp ® (NyQuil Cold & Flu w/VapoCOOL, 4ct (PE-free), CVP ®)

VICKS

NyQuil™

COLD & FLU

Acetaminophen, Docylamine

Succinate, Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

VapoCOOL

COATED

4 Coated Caplets

[CVP ® HEALTH logo]

Nyquil Cold & Flu W/vapocool, 4ct (pe Free), Travel Basix (NyQuil Cold & Flu w/VapoCOOL, 4ct (PE-free), Travel BASIX)

VICKS

NyQuil™

COLD & FLU

Acetaminophen, Docylamine

Succinate, Dextromethorphan HBr

[caplet image]

Headache, Fever, Sore Throat,

Minor Aches & Pains

Cough

VapoCOOL

COATED

4 Coated Caplets

[Travel BASIX logo]


Advanced Ingredient Data


Raw Label Data

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