Other
Drug Facts
Dist. by
Procter & Gamble,
Cincinnati OH 45202.
Vicks Nyquil Liquid
FDA Label NDC 69423-999
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Nyquil (NDC 69423-999). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients
(in each 30 mL dose cup) | Purpose |
|---|---|
| Dextromethorphan HBr 30 mg | Cough suppressant |
| Doxylamine succinate 12.5 mg | Antihistamine |
| Phenylephrine HCl 5 mg | Nasal decongestant |
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
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 sleep
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
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 | do not use unless directed by a doctor |
| children under 4 yrs | do not use |
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
Questions?
1-800-362-1683
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)
Vicks (Vicks)
* Please review the disclaimer below.
