FDA Label for Vicks Dayquil Nyquil Hot Remedy Rapid Relief Multi-symptom Cold And Flu Plus Congestion
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- ALLERGY ALERT
- SORE THROAT WARMING
- PRINCIPAL DISPLAY PANEL - 16 PACKET PACKAGE
Vicks Dayquil Nyquil Hot Remedy Rapid Relief Multi-symptom Cold And Flu Plus Congestion 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 RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION
Drug Facts
MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
Vicks® NyQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION
Drug Facts
MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
Otc - Active Ingredient
Active Ingredient (in each packet) Purpose
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Active Ingredient (in each packet) Purpose
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Otc - Purpose
Active Ingredient (in each packet) Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Active Ingredient (in each packet) Purpose
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
• minor aches & pains
• sore throat
• fever
• headache
• cough due to minor throat & bronchial irritation
• cough to help you sleep
• nasal congestion
• sinus congestion & pressure
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
temporarily relieves common cold/flu symptoms:
• minor aches & pains
• sore throat
• fever
• headache
• cough due to minor throat & bronchial irritation
• cough to help you sleep
• nasal congestion
• sinus congestion & pressure
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• runny nose
• sneezing
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
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.
- with any other product containing diphenhydramine, even one used on the 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
- with any other product containing diphenhydramine, even one used on the skin.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional
acetaminophen, ask a doctor or pharmacist.
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- trouble urinating due to enlarged prostate gland
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, 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 the blood thinning drug warfarin
- taking sedatives or tranquilzers
When Using This Product
do not use more than directed
• Do not use more than directed
• 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
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.
- 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.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Keep out of reach of children.
Overdose Warning
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.
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.
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
Adults & children 12 yrs & over - one packet (dose) every 4 hours
Children under 12 yrs - Do not use
• 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
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 64 mg per dose
• do not exceed 25°C.
• each packet contains: potassium 10 mg
• phenylketonurics: contains phenylalanine 68 mg per dose
• do not exceed 25°C
Inactive Ingredients
acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate
acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate
Questions?
1-800-362-1683
1-800-362-1683
Allergy Alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddening
- Blisters
- Rash
Sore Throat Warming
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.
Principal Display Panel - 16 Packet Package
MAX STRENGTH
Vicks® DayQuil™ HOT REMEDY
Acetaminophen - Headache, Fever, Sore Throat, Minor Aches & Pains
Dextromethorphan HBr - Cough
Phenylephrine HCl - Nasal Congestion, Sinus Pressure
Vicks® NyQuil™ HOT REMEDY
Acetaminophen - Headache, Fever, Sore Throat, Minor Aches & Pains
Diphenhydramine HCl - Sneezing, Runny Nose, Cough
Phenylephrine HCl - Nasal Congestion, Sinus Pressure
RAPID RELIEF
MULTI-SYMPTOM
COLD & FLU + CONGESTION
Nighttime Relief
HONEY LEMON TEA FLAVORED
10 DAYQUIL POWDER PACKETS; 6 NYQUIL POWDER PACKETS; 16 TOTAL POWDER PACKETS
* Please review the disclaimer below.