Active Ingredients For Nighttime (In Each 20 Ml)
Acetaminophen 650 mg
Diphenhydramine HCI 25 mg
Phenylephrine HCI 10 mg
Daytime Mucus Relief Severe Congestion And Cough And Nighttime Cold And Flu Kit
FDA Label NDC 0363-0862
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 Mucus Relief Severe Congestion And Cough And Nighttime Cold And Flu (NDC 0363-0862). 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 for nighttime (in each 20 ml), active ingredients for daytime (in each 20 ml), purpose for nighttime, purpose for daytime, uses, warnings, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients For Daytime (In Each 20 Ml)
Dextromethorphan HBr 20 mg
Guaifeenesin 400 mg
Phenylephrine HCl 10 mg
Purpose For Nighttime
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Purpose For Daytime
Cough suppressant
Expectorant
Nasal decongestant
Uses
Nighttime
- temporarily relieves these common cold and flu symptoms
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- temporarily reduces fever
- controls cough to help you get to sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
- temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
Daytime
Warnings
NIGHTTIME
Liver warning: This product contain acetaminophen. Severe liver damage may occur if you take
- 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.
Do Not Use
Nighttime
- with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other drug containing diphenhydramine, even one used on the skin
- 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
- for children under 12 years of age
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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.
- for children under 12 years of age
Daytime
Ask A Doctor Before Use If You Have
Nighttime
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema
- cough that occurs with too much phlegm (mucus)
Daytime
Ask A Doctor Or Pharmacist Before Use If You Are
Nighttime
- taking the blood thinning drug warfarin
- taking sedative or tranquilizers
When Using These Products
Nighttime
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicile or operating machinery
- do not use more than directed
Daytime
Stop Use And Ask A Doctor If
Nighttime
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 7 days
- 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 a signs of a serious condition
- nervousness, dizziness or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- cough comes back, or occur with fever, rash, or headache that lasts. These could be signs of a serious condition.
Daytime
If Pregnant Or Breast-Feeding,
Nighttime
ask a health professional before use.
Daytime
ask a health professional before use
Keep Out Of Reach Of Children.
Nighttime
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 adults as well as for children even if you do not notice any signs or symptoms.
Daytime
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Nighttime
- do not take more than directed (see overdose warning)
- do not take more than 6 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 = mililiter
- dose as follows or as directed by a doctor
- adults and children 12 years and older: 20 mL every 4 hours while symptoms last
- children under 12 years of age: do not use
- do not take more than 6 doses in any 24-hours period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = mililiter
- shake well before using
- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Daytime
Other Information
Nighttime
- each 20 mL contains: sodium 12 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
- each 20 mL contains: 17 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Daytime
Inactive Ingredients
Nighttime
citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Daytime
citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
Nighttime
Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST
Daytime
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough & Night Time Cold & Flu active ingredient††
NIGHTTIME
Cold & Flu
ACETAMINOPHEN /
PAIN RELIEVER & FEVER REDUCER
DIPHENHYDRAMINE HCI /
ANTIHISTAMINE / COUGH SUPPRESSANT
PHENYLEPHRINE HCI /
NASAL DECONGESTANT
MAXIMUM STRENGTH
- Relieves aches, fever, sore throat, nasal congestion, runny nose, & sneezing
- Controls cough
- For ages 12 & over
- Controls Cough
- Clears nasal & chest congestion
- Thins & loosens mucus
- For ages 12 & over
DAYTIME
Severe Congestion & Cough
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCI / NASAL DECONGESTANT
MAXIMUM STRENGTH
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Severe Congestion & Cough & Nighttime Cold & Flu.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Product Label
WALGREENS NIGHTTIME Cold & flu, DAYTIME Severe Congestion & Cough
* Please review the disclaimer below.
