FDA Label for Vicks Dayquil And Vicks Nyquil Cold And Flu
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- LIVER WARNING:
- SORE THROAT WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- ALLERGY ALERT:
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- OTC - KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL - CONVENIENCE PACK
Vicks Dayquil And 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
NyQuil Cold & Flu
Drug Facts
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
DIST. BY: PROCTER & GAMBLE,
CINCINNATI, OH 45202
DayQuil Cold & Flu
Drug Facts
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.
Tamper Evident: Do not use if printed shrinkband seal around the neck is broken or missing.
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
Pain reliever/Fever reducer
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
- runny nose and sneezing
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
temporarily relieves common cold/flu symptoms:
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 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
- adults take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
- child take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
This product contains acetaminophen. Severe liver damage may occur if
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.
- 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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
Otc - When Using
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
When using this product, do not use more than directed.
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.
- You get nervous, dizzy, or sleepless.
- Pain, nasal congestion or cough get worse or last more than 5 days (children) or 7 days (adults)
- Fever gets worse or last 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.
Keep Out Of Reach Of Children.
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
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
- 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 every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
| 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 | ask a doctor |
| children under 4 yrs | do not use |
Other Information
- each 30 mL contains: sodium 24 mg
- store at no greater than 25°C and do not refrigerate
- each 15 mL contains: sodium 46 mg
- store at no greater than 25°C and do not refrigerate.
Inactive Ingredients
alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate,
sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Questions?
1-800-362-1683
1-800-362-1683
Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
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
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Principal Display Panel - Convenience Pack
POWERFUL
RELIEF
DAY& NIGHTPACK
VICKS®DayQuil™
COLD & FLU
Acetaminophen,Phenylephrine HCl, Dextromethorphan HBr
Headache, Fever, Sore Throat, Minor Aches & Pains
Nasal Congestion, Sinus Pressure
Cough
Non-Drowsy
Alcohol Free
VICKS ®NyQuil ™
COLD & FLU
Acetaminophen,Doxylamine Succinate, Dextromethorphan HBr
Headache, Fever, Sore Throat Minor Aches & Pains
Sneezing, Runny Nose
Cough
Nighttime Relief
Alcohol 10%
TWO 12 FL OZ (354 ml) BOTTLES
TOTAL 24 FL OZ (708 ml)
* Please review the disclaimer below.