Active Ingredients (In Each 15 Ml) – Nighttime
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Walgreen Day Time Nighttime Cold And Flu Relief
FDA Label NDC 0363-6120
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 Co. for the product Walgreen Day Time Nighttime Cold And Flu Relief (NDC 0363-6120). 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) – nighttime, purpose, uses, warnings, do not use, ask a doctor or pharmacist before use if you are, if pregnant or breast-feeding, ask a health professional before use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion and pressure
- minor aches and pains
- headache
- fever
- sore throat
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- cough to help you sleep
- reduces swelling of nasal passages
- promotes nasal and/or sinus drainage
- temporarily restores freer breathing through the nose
- nasal congestion
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- minor aches and pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves common cold/flu symptoms:
Warnings
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
- Skin reddening
- Blisters
- Rash
- 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
- 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.
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
- 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.
- to make child sleepy
- 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 Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin.
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 at 1-800-222-1222. 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 4 hrs |
children 6 to under 12 yrs | 15mL every 4 hrs |
children under 4 to under 6 yrs | do not use unless directed by 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 | 15mL every 4 hrs |
children under 4 to under 6 yrs | ask a doctor |
Children under 4 yrs | do not use |
Other Information
- each 15 mL contains: sodium 9 mg
- store at room temperature
- Do not refrigerate
- each 15 mL contains: sodium 9 mg
- store at room temperature.
- Do not refrigerate.
Inactive Ingredients
citric acid, D&C yellow #10, edetate disodium, FD&C Green No 3, FD&C Red No.40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
citric acid, D&C yellow #10, edetate disodium,
FD&C Green #3, FD&C Red No. 40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
Active Ingredients (In Each 15 Ml) - Day Time
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
When Using This Product
do not use more than directed
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package/Label Principal Display Panel
VALUE PACK
*Compare to the active ingredients in Vicks® Dayquil™ Severe cold & Flu Honey Flavor
DayTime
Cold & Flu
Relief
Acetaminophen - Pain reliever / Fever reducer
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal decongestant
Dextromethorphan HBr - Cough supressant
- Headache, Fever, sore Throat, Minor Aches & Pains
- Chest Congestion Thins & Loosen Mucus
- Nasal Congestion & Sinus Pressure
- Cough
- Headache, Fever, Sore Throat, Minor Aches & Pains,
- Nasal Congestion & Sinus Pressure
- Sneezing, Runny Nose
- Cough
Honey Flavor
Naturally and Artificially Flavored
TWO BOTTLES, 12 FL OZ (354 mL)
**Compare to the active ingredients in Vicks® Nyquil™ Severe cold & Flu Honey Flavor
Nighttime
Cold & Flu
Relief
Acetaminophen - Pain reliever / Fever reducer
Phenylephrine HCl - Nasal decongestant
Doxylamine succinate - Antihistamine
Dextromethorphan HBr - Cough supressant
For Relief of
Honey Flavor
Naturally and Artificially Flavored
Each; TOTAL 24 FL OZ (708 mL)
* Please review the disclaimer below.
