DAYTIME NIGHTTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, doxylamine succinate, phenylephrine hcl 
CVS HEALTH CORP

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627T CVS Daytime Nighttime Severe Cold and Flu

Daytime Severe Cold and Flu - Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

-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

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

Ask a doctor before use if you have

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

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. In case of overdose, get medical help or contact a Poison Control Center right away (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.

Directions

Other information

Inactive ingredients FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions or comments? Call 1-877-290-4008

Nighttime Severe Cold and Flu - Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses temporarily relieves common cold/flu symptoms:

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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.

In case of overdose, get medical help or contact a Poison Control Center right away (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.

Directions

adults & children 12 yrs & over2 softgels with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions or comments? Call 1-877-290-4008

627T 24ct

CVS 627T 24ct

627T 48ct

CVS 627T 48ct

DAYTIME NIGHTTIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-527
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-527-242 in 1 CARTON02/01/2025
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51316-527-484 in 1 CARTON02/01/2025
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 16   in 2 
Part 22 BLISTER PACK 8   in 2 
Part 1 of 2
DAYTIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule
Product Information
Item Code (Source)NDC:51316-525
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SORBITOL (UNII: 506T60A25R)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SHELLAC (UNII: 46N107B71O)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColororangeScoreno score
ShapeBULLETSize16mm
FlavorImprint Code 73
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/01/2025
Part 2 of 2
NIGHTTIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule
Product Information
Item Code (Source)NDC:51316-526
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorgreenScoreno score
ShapeBULLETSize16mm
FlavorImprint Code 72
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/01/2025
Labeler - CVS HEALTH CORP (062312574)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(51316-527)

Revised: 3/2026
Document Id: 4d1d8a10-476d-1352-e063-6294a90a1279
Set id: 23e2d2dc-12d4-294d-e063-6394a90a9523
Version: 3
Effective Time: 20260316
 
CVS HEALTH CORP