Vicks® Nyquil™

Vicks® Nyquil™
SPL v9
SPL
SPL Set ID c4d38921-ec90-0658-e053-2a95a90a848a
Route
ORAL
Published
Effective Date 2023-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Sucralose Xanthan Gum Glycerin Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40 Sodium Chloride Sodium Benzoate Propylene Glycol Water Saccharin Sodium Sodium Citrate Sorbitol

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-08

Description

Drug Facts

Purpose

Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Cough suppressant

Antihistamine

Nasal decongestant

Description

Drug Facts

Uses

temporarily relieves cold symptoms:

• nasal congestion

• sinus congestion & pressure

• cough due to minor throat & bronchial irritation

• cough to help you sleep

• 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.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9

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

Directions
  • take only as directed
  • only use 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 not use unless directed by a doctor
children under 4 yrs do not use

Do Not Use
  • 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.
  • to make a child sleepy
Questions?

1-800-362-1683

Other Information
  • each 15 mL dose cup contains: sodium 44 mg
  • store at no greater than 25°C
Inactive Ingredients

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

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
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash, or persistent headache.

These could be signs of a serious condition.

Active Ingredients (in Each 15 Ml)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

• 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

• a sodium-restricted diet

Principal Display Panel 236 Ml Bottle Label

VICKS ®

NyQuil™

COUGH DM + CONGESTION

Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate

  • Cough
  • Nasal Congestion
  • Sneezing, Runny Nose

8 FL OZ (236 ml)

Nighttime Relief


Structured Label Content

Uses

temporarily relieves cold symptoms:

• nasal congestion

• sinus congestion & pressure

• cough due to minor throat & bronchial irritation

• cough to help you sleep

• 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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9 (53414-9)

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

Purpose

Cough suppressant

Antihistamine

Nasal decongestant

Directions
  • take only as directed
  • only use 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 not use unless directed by a doctor
children under 4 yrs do not use

Do Not Use (Do not use)
  • 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.
  • to make a child sleepy
Questions?

1-800-362-1683

Other Information (Other information)
  • each 15 mL dose cup contains: sodium 44 mg
  • store at no greater than 25°C
Inactive Ingredients (Inactive ingredients)

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

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
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash, or persistent headache.

These could be signs of a serious condition.

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

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• 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

• a sodium-restricted diet

Principal Display Panel 236 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label)

VICKS ®

NyQuil™

COUGH DM + CONGESTION

Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate

  • Cough
  • Nasal Congestion
  • Sneezing, Runny Nose

8 FL OZ (236 ml)

Nighttime Relief


Advanced Ingredient Data


Raw Label Data

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