Active Ingredients (In Each 15 Ml) Daytime
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Daytime Nighttime Cold And Cough Kit
FDA Label NDC 0363-4670
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Daytime Nighttime Cold And Cough (NDC 0363-4670). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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 have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 common cold/flu symptoms
- minor aches and pain
- headache
- sore throat
- runny nose and sneezing
- fever
- cough due to minor throat and bronchial irritations as may occur with a cold
NIGHTTIME
Warnings
DAYTIME NIGHTTIME
Liver warning: This product contain 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.
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 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 contain an MAOI, ask a doctor or pharmacist before taking this product
Ask A Doctor Before Use If Have
DAYTIME
- liver disease
- high blood pressure
- heart disease
- 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)
- trouble urinating due to enlarged prostate gland
- a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If The Child Is
DAYTIME
if you are 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
- mark 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.
- pain or cough gets worse or lasts more than 7 days
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- 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.
Overdose warning: 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 adult 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-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL= milliliter
- adult and children 12 years and over: 30 mL every 6 hours
- children under 12 years of age: do not use
| adult 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°F). Do not refrigerate.
- each 30 mL contains: potassium 5 mg
- each 30 mL contains: sodium 19 mL
- store between 20-25°C (68-77°F). Do not refrigerate
NIGHTTIME
Inactive Ingredients
DAYTIME
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
NIGHTTIME
acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow #10 FD&C green #3, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, trisodium citrate dihydrate
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Vick® Dayquil® and Vick® Nyquil® Cold & Flu††
DAYTIME • NON-DROWSY
Cold & Cough
ACETAMINOPHEN /
ACHES / FEVER / SORE THROAT
DEXTROMETHORPHAN HBr / COUGH
PHENYLEPHRINE HCI / NASAL DECONGESTANT
MULTI-SYMPTOM
- Pain reliever, fever reducer, cough suppressant & nasal decongestant
- Anti-histamine free
- Alcohol free
- Pain reliever, fever reducer, cough suppressant & antihistamine
- ALCOHOL 10%
FL OZ (mL)
NIGHTTIME
Cold & Flu
ACETAMINOPHEN /
ACHES / FEVER / SORE THROAT
DEXTROMETHORPHAN HBr / COUGH
DOXYLAMINE SUCCINATE / SNEEZING / RUNNY NOSE
MULTI-SYMPTOM
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
††This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® and Nyquil® are registered trademarks of the Procter & Gamble Company.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015 walgreens.co,
Product Label
WALGREENS Daytime Nighttime Cold and Flu Relief
* Please review the disclaimer below.
