FDA Label for Vicks Nyquil Cold And Flu
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- LIVER WARNING:
- ALLERGY ALERT:
- SORE THROAT WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
Vicks Nyquil Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
DIST. BY
PROCTER & GAMBLE,
CINCINNATI, OH 45202
Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- cough to help you sleep
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses (30 mL each dose) 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
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
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.
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.
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
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- 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
- 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,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL per dose every 6 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
- each 30 mL contains: sodium 25 mg
- store at no greater than 25°C (77°F) and do not refrigerate
Inactive Ingredients
alcohol, anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum
Questions?
1-800-362-1683
Principal Display Panel - 118 Ml Bottle Label
VICKS ®
NyQuil™
COLD & FLU
Acetaminophen -
Pain Reliever/Fever Reducer
Doxylamine Succinate - Antihistamine
Dextromethorphan HBr -
Cough Suppressant
Nighttime Relief
Alcohol 10%
4 FL OZ (118 mL)
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