FDA Label for Daytime Nighttime Cold And Flu
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 15 ML) DAYTIME
- ACTIVE INGREDIENTS FOR (IN EACH 30 ML) NIGHTTIME
- PURPOSES FOR DAY TIME
- PURPOSE FOR NIGHT TIME
- USES
- WARNINGS
- 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,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Daytime Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. 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.
Active Ingredients (In Each 15 Ml) Daytime
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active Ingredients For (In Each 30 Ml) Nighttime
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Purposes For Day Time
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purpose For Night Time
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
DAYTIME
- temporarily relieves common cold and flu symptoms
- minor aches and pains
- headache
- sore throat
- nasal congestion
- fever
- cough due to minor throat and bronchial irritation
- temporarily relieves these common cold/flu symptoms`
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing
- fever
- cough due to minor throat and bronchial irritation
NIGHTTIME
Warnings
DAYTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
- child takes more than 4 doses (15 mL each) in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash.
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash.
Allergy alert: 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.
NIGHTTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: 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.
Do Not Use
DAYTIME NIGHTTIME
- 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask A Doctor Before Use If You Have
DAYTIME
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
- 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
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If You Are
DAYTIME
taking the blood thinning drug warfarin.
NIGHTTIME
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
DAYTIME
do not exceed recommended dosage.
NIGHTTIME
- 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
DAYTIME
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)
- 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.
NIGHTTIME
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.
DAYTIME NIGHTTIME
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center(1-800-222-1222) 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
DAYTIME
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL= milliliter
- do not take more than directed (see Overdose warning)
- Do not take more than 4 doses in any 24-hours period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years of age: do not use
- when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing
adults and children 12 years and over | 30 mL every 4 hours |
children 6 to under 12 years | 15 mL every 4 hours |
children 4 to under 6 years | ask a doctor |
children under 4 years | do not use |
NIGHTTIME
Other Information
DAYTIME
- each 15 mL contains: sodium 12 mg
- store between 20-25°C (68-77°). Do not refrigerate
- each 30 mL contains: potassium 5 mg
- each 30 mL contains sodium 24 mg
- store between 20-25°C (68-77°F). Do not refrigerate
NIGHTTIME
Inactive Ingredients
Day Time
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Night Time
acesulfame potassium, alcohol, anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium trisodium citrate dihydrate
Questions Or Comments?
Call 1-800-824-1706 Monday-Friday 9AM-4PM MST
Principal Display Panel
*Compare to the active ingredients in VICKS® DayQuil® & NyQuil® Cold & Flu
MULTI-SYMPTOM
Cold & Flu Relief
NON-DROWSY
Daytime
ACETAMINOPHEN / PAIN RELIEVER - FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
PHENYLEPHRINE HCI / NASAL DECONGESTANT
Relieves: Aches, Fever, Sore Throat, Cough & Nasal Congestion
NIGHT TIME
ACETAMINOPHEN / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE / ANTIHISTAMINE
ALCOHOL 10%
Relieves: Aches, Fever, Sore Throat, Cough, Sneezing & Runny Nose
CHERRY FLAVOR
FL OZ (mL)
*This product is not manufactured or distributed by THE PROCTER & GAMBLE COMPANY. VICKS® DayQuil® and NyQuil® are registered trademarks of THE PROCTER & GAMBLE COMPANY.
WHEN USING OTHER DAYTIME OR NIGHTTIME PRODUCTS, CAREFULLY READ EACH LABEL TO ENSURE CORRECT DOSING.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
WINCO FOODS, LLC, BOISE ID 83704
Product Label
WINCO FOODS Daytime Nighttime Multi-Symptom Cold & Flu Relief Cherry Flavor
* Please review the disclaimer below.