Active Ingredients For Day Time (In Each 20 Ml)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Daytime Mucus Relief Severe Congestion And Cough And Nighttime Cold And Flu Kit
FDA Label NDC 69842-462
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Daytime Mucus Relief Severe Congestion And Cough And Nighttime Cold And Flu (NDC 69842-462). 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 day time (in each 20 ml), active ingredients for night time (in each 20 ml), purposes for day time, purpose for night time, 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 Night Time (In Each 20 Ml)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Purposes For Day Time
Cough suppressant
Expectorant
Nasal decongestant
Purpose For Night Time
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
Uses
Daytime
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways 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 irritant
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
- temporarily relievesthese 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
Nighttime
Warnings
Nighttime
Liver warning :
This product contains 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
Daytime
- if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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
- With any other 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 taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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
Nighttime
Ask A Doctor Before Use If You Have
Daytime
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
- cough that occurs with too much phlegm (mucus)
- 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)
Nighttime
Ask A Doctor Or Pharmacist Before Use If
Nighttime
- you are taking the blood thinning drug warfain
- you are taking sedatives or tranquilizers
When Using This Product
Daytime
do not use more than directed.
Nighttime
- do not use more than directed
- excitability may occur, especially in children
- marked drowsinessmay occur
- alcohol, sedative, and tranquilizers may increase drowsiness
- avoid alcohol drinks
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
Daytime
- nervousness, dizziness or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- cough comes back, or occurs with fever, rash, or headache that lasts.
- 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 fever, 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,
Daytime
ask a health professional before use
Nighttime
ask a health professional before use
Keep Out Of Reach Of Children.
Daytime
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 adult as well as for children even if you do not notice any signs or symptoms
Directions
Daytime
- 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= milliliter
- shake well before using
- adult and children 12 years of age and older: 20 mL in dosing cup provided avery 4 hours
- Children under 12 years of age do not use
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in any24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL= milliliter
- dose as follows or as directed by a doctor
- adult and children 12 years and older: 20 mL every 4 hours while symptoms last
- children under 12 years of age: do not use
Nighttime
Other Information
Daytime
- each 20 mL contains: sodium 17 mg
- store at 20-25°C (68-77°F). Do not refrigerate.
- each 20 mL contains: sodium 10 mg
- store at 20-25°C (68-77°F). Do not refrigerate
Nighttime
Inactive Ingredients
Inactive ingredients for Day Time
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
Inactive ingredients for Night Time
citric acid, EDTA disodium, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Principal Display Panel
DAYTIME
Severe Cough & Congestion
DEXTROMETHORPHAN HBr - Cough Suppressant
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCI - Nasal Decongestant
MAXIMUM STRENGTH
Multi-Symptom
- Relieves nasal & chest congestion
- Soothes Cough
- Thins & loosen mucus
- Relieves headache & fever
- Controls cough
- Relieves nasal congestion
- Relieves runny nose & sneezing
For ages 12 & over
FL OZ (mL)
Compare to the active ingredients in Maximum Strength Mucinex®FAST-MAX® Severe Congestion & Cough and Nighttime Cold & Flu*
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
NIGHTTIME
Cold & FLU
ACETAMINOPHEN - Pain Reliever ; Fever Reducer
DIPHENHYDRAMINE HCl - Antihistamine / Cough Suppressant
PHENYLEPHRINE HCl / Nasal Decongestant
MAXIMUM STRENGTH
Multi-Strength
For ages 12 & over
FL OZ (mL)
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com
Product Label
CVS HEALTH Severe Cough & Congestion Nighttime Cold & Flu
* Please review the disclaimer below.
