MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF- acetaminophen dextromethorphan hbr guaifenesin phenylephrine hcl and acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl 
CVS Pharmacy, Inc.

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.

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630T CVS 69842-442 MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF

DRUG FACTS

Active ingredients (in each softgel)
Daytime Sinus Relief
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Active ingredients (in each softgel)
Nighttime Sinus Relief

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCI 5 mg

Purposes
Daytime Sinus Relief
Pain reliever
Cough suppressant
Expectorant
Nasal decongestant

Purposes
Nighttime Sinus Relief
Pain reliever
Cough suppressant
Antihistamine
Nasal decongestant

Uses

cough

minor aches and pains

headache
nasal congestion
sinus congestion and pressure
runny nose and sneezing ( Nighttime only)

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.

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

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 (overdose) may cause liver damage. 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

other information

Inactive ingredients (Daytime only)
FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water.

Inactive ingredients (Nighttime only)
FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

Questions?call 1-877-290-4008

Maximum strength day time and nightime sinus relief - cvs -24s carton

MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF 
acetaminophen dextromethorphan hbr guaifenesin phenylephrine hcl and acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-442
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-442-241 in 1 CARTON07/10/2021
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 16 
Part 21 BLISTER PACK
Part 1 of 2
MAXIMUM STRENGTH DAYTIME SINUS RELIEF 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
Product Information
Item Code (Source)NDC:69842-617
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize24mm
FlavorImprint Code PC26
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-617-1616 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/10/2021
Part 2 of 2
MAXIMUM STRENGTH NIGHTTIME SINUS RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled
Product Information
Item Code (Source)NDC:69842-290
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-290-088 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/10/2021
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(69842-442)

Revised: 7/2021
Document Id: c6726e12-06a6-0370-e053-2a95a90a7dd6
Set id: c17d5ba7-3302-7931-e053-2a95a90a5a6c
Version: 2
Effective Time: 20210706
 
CVS Pharmacy, Inc.