FDA Label for Walgreen Day Time Nighttime Cold And Flu Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 30 ML) – NIGHTTIME
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- ACTIVE INGREDIENTS (IN EACH 30 ML) - DAY TIME
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Walgreen Day Time Nighttime Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Co.. 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 30 Ml) – Nighttime
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
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.• 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.
When Using This Product
• do not use more than directed• 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
do not use more than directed
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. These could be signs of a serious condition.• 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.
Directions
• take only as directed – see Overdose warning• 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 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 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
• each 30 mL contains: sodium 81 mg• store at room temperature• Do not refrigerate• each 30 mL contains: sodium 81 mg• store at room temperature.• Do not refrigerate.
Inactive Ingredients
citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose
citric acid, D&C yellow #10, edetate disodium,
FD&C blue #1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose
Questions Or Comments?
1-866-467-2748
Active Ingredients (In Each 30 Ml) - Day Time
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
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+ VapoCOOL™
DayTime
Cold & Flu
Relief
Acetaminophen - Pain reliever / Fever reducer
Dextromethorphan HBr - Cough supressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal decongestant
For Relief of
• Minor Aches & Pains, Fever• Nasal Congestion & Sinus Pressure• Cough• Chest Congestion• Minor Aches & Pains, Fever• Nasal Congestion & Sinus Pressure• Sneezing, Runny Nose• Cough
TWO BOTTLES, 12 FL OZ (354 mL)
**Compare to the active ingredients in Vicks® Nyquil® Severe+ VapoCOOL™
NightTime
Cold & Flu
Relief
Acetaminophen - Pain reliever / Fever reducer
Dextromethorphan HBr - Cough supressant
Doxylamine succinate - Antihistamine
Phenylephrine HCl - Nasal decongestant
For Relief of
Each; TOTAL 24 FL OZ (708 mL)
* Please review the disclaimer below.