CVS DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS- acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CVS Daytime Severe Cold and Flu Relief

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Guaifenesin 200 mg

Phenlyephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Warnings

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.

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

Inactive ingredients

FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol
sorbitan solution, titanium dioxide

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

image description


CVS DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS 
acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-545
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (Light Orange) Scoreno score
ShapeCAPSULE (oblong shaped) Size20mm
FlavorImprint Code 341
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-545-242 in 1 CARTON06/05/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/05/2019
Labeler - CVS Pharmacy (062312574)
Registrant - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PRIVATE LTD677385498manufacture(69842-545)

Revised: 12/2020
Document Id: b5e2ac00-98fb-674e-e053-2a95a90abf0d
Set id: b9183e27-037a-4e54-bbc0-837014e503af
Version: 4
Effective Time: 20201207
 
CVS Pharmacy