FDA Label for Vicks Nyquil Hot Remedy Cold And Flu
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH PACKET)
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,ASK A HEALTH PROFESSIONAL BEFORE USE.
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS:
- QUESTIONS?
- WHEN USING THIS PRODUCT
- IF PREGNANT OR BREAST-FEEDING,
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 6 PACKET PACKAGE
Vicks Nyquil Hot Remedy Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Procter & Gamble Manufactura S De Rl De Cv. 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
Vicks® DayQuil™ HOT REMEDY COLD & FLU
Drug Facts
DayQuil™
MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
Vicks® NyQuil™ HOT REMEDY COLD & FLU
Drug Facts
NyQuil™
MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
Active Ingredient (In Each Packet)
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Purpose
Headache, Fever, Sore Throat, Minor Aches & Pains
Cough
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- minor aches & pains
- sore throat
- fever
- headache
- cough due to minor sore throat & bronchial irritation
- cough to help you sleep
- runny nose
- sneezing
temporarily relieves common cold/flu symptoms:
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 doses 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
- more than 6 doses 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
This product contains acetaminophen. Severe liver damage may occur if you take
Allergy Alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddening
- Blisters
- Rash
- Skin reddening
- Blisters
- Rash
If a skin reaction occurs, stop use and seek medical help right away
Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin.
- 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
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- 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 the blood thinning drug warfarin
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
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.
- 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.
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,Ask A Health Professional Before Use.
Keep Out Of Reach Of Children.
Directions
- take only as directed
- do not exceed 6 doses per 24 hrs
- Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes
- If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat
- take only as directed
- do not exceed 6 doses per 24 hrs
- Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes
- If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat
| Age | Dose |
| adults & children 12 yrs & over | one packet (dose) every 4 hours |
| children under 12 yrs | do not use |
| Age | Dose |
| adults & children 12 yrs & over | one packet (dose) every 4 hours |
| children under 12 yrs | do not use |
Other Information
- each packet contains: potassium 10 mg
- phenylketonurics: contains phenylalanine 68 mg per dose
- store at no greater than 25°C (77°F)
- phenylketonurics: contains phenylalanine 68 mg per dose
- store at no greater than 25°C (77°F)
• each packet contains:potassium 10 mg
Inactive Ingredients:
acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor, sodium citrate, sucrose, tricalcium phosphate
Questions?
1-800-362-1683
1-800-362-1683
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Inactive Ingredients
acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor, sodium citrate, sucrose, tricalcium phosphate
Principal Display Panel - 6 Packet Package
NEW FORMULAS
VALUE PACK
Vicks ®DayQuil™ HOT REMEDY
COLD & FLU
Acetaminophen,Dextromethorphan HBr
Headache, Fever, Sore Throat, Minor Aches & Pains
Cough
Non-Drowsy
Vicks ®NyQuil™ HOT REMEDY
COLD & FLU
Acetaminophen, Diphenhydramine HCl
Headache, Fever, Sore Throat, Minor Aches & Pains
Cough, Sneezing, Runny Nose
Nighttime Relief
HONEY LEMON FLAVORED
3 DAYQUIL PACKETS; 3 NYQUIL PACKETS; 6 TOTAL PACKETS
* Please review the disclaimer below.
