Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Guaifenesin 200 mg
Phenlyephrine HCl 5 mg
Cvs Daytime Severe Cold And Flu Relief Softgels
FDA Label NDC 69842-545
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 Cvs Daytime Severe Cold And Flu Relief Softgels (NDC 69842-545). 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 softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product,, 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
Expectorant
Nasal decongestant
Uses
- ■ temporarily relieves common cold/flu
symptoms: ■ nasal congestion ■ sinus
congestion & pressure ■ cough due to minor throat
& bronchial irritation ■ minor aches & 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.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 softgels 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.
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.
Ask A Doctor Before Use If You Have
- liver disease
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- 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)
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product,
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.
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 can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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
■ do not exceed 8 softgels per 24 hours
| adults & children 12 years
& over | 2 softgels with water
every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
■ when using other Nighttime or Daytime products,
carefully read each label to ensure correct dosing
Other Information
- ■ store at room temperature
Inactive Ingredients
FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol
sorbitan solution, titanium dioxide
Otc - Questions
Questions or comments? 1-888-333-9792
Principal Display Panel
Compare to the active ingredients in Vick® DayQuil® Cold & Flu*
MAXIMUM STRENGTH
Daytime Softgels
Severe Cold/Flu Relief
ACETAMINOPHEN - Pain reliever; fever reducer
DEXTROMETHORPHAN HBr - Cough Suppressant
GUAIFENESIN- Expectorant
PHENYLEPHRINE HCl - Nasal Decongestant
Relieves:
Headache, Fever, Sore throat, Minor aches
& pains, Cough, Chest congestion, Nasal/Sinus
congestion & Sinus pressure
Non-drowsy
Alcohol free
Antihistamine free
24 SOFTGELS
THIS PRODUCT IS
PACKAGED IN A
CHILD-RESISTANT AND
TAMPER-EVIDENT
PACKAGE. USE ONLY IF
BLISTERS ARE INTACT.
*This product is not
manufactured or distributed
by Procter & Gamble, owner
of the registered trademarks
Vicks® DayQuil® Severe Cold
& Flu.
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
V-35249
* Please review the disclaimer below.
