Nyquil™ Severe+ Vapocool™ Cold & Flu

Nyquil™ Severe+ Vapocool™ Cold & Flu
SPL v7
SPL
SPL Set ID e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b
Route
ORAL
Published
Effective Date 2022-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Crospovidone (15 Mpa.s At 5%) D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Blue No. 2 Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Starch, Corn Silicon Dioxide Stearic Acid Sucralose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: NQ Shape: oval Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-29

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 53414-9

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

Section 55105-1
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
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
  • 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

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

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
  • do not exceed 25°C
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

crospovidone, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

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, and 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.

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
Nyquil™ Severe + Vapocool™ C & F Cvp Health Pdp/package

NyQuil™

SEVERE+

VICKS ® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

[caplet image]

Nighttime Relief

4

Coated Caplets

[CVP ® HEALTH logo]

Nyquil™ Severe+ Vicks® Vapocool™ Travel Basix Pdp/package

NyQuil™

SEVERE+

VICKS® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

[caplet image]

4

Coated Caplets

[TRAVEL BASIX logo]

Nyquil™ Severe Plus Vapocool™ C & F Lil' Drug Store Pdp/package

NyQuil™



SEVERE+

VICKS ® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,



Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

4



Coated Caplets

Lil'



DrugStore ®


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
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.
Questions?

1-800-362-1683

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)
  • do not exceed 25°C
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)

crospovidone, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

When Using This Product (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, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Nyquil™ Severe + Vapocool™ C & F Cvp Health Pdp/package (NyQuil™ Severe + VapoCOOL™ C & F - CVP Health PDP/Package)

NyQuil™

SEVERE+

VICKS ® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

[caplet image]

Nighttime Relief

4

Coated Caplets

[CVP ® HEALTH logo]

Nyquil™ Severe+ Vicks® Vapocool™ Travel Basix Pdp/package (NyQuil™ SEVERE+ VICKS® VapoCOOL™ - TRAVEL BASIX PDP/Package)

NyQuil™

SEVERE+

VICKS® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

[caplet image]

4

Coated Caplets

[TRAVEL BASIX logo]

Nyquil™ Severe Plus Vapocool™ C & F Lil' Drug Store Pdp/package (NyQuil™ Severe Plus VapoCOOL™ C & F - Lil' Drug Store PDP/Package)

NyQuil™



SEVERE+

VICKS ® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,



Doxylamine Succinate, Dextromethorphan HBr

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

4



Coated Caplets

Lil'



DrugStore ®


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Raw Label Data

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