DAYTIME NIGHTTIME COLD/FLU - acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 
Velocity Pharma

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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Acetaminophen, Dextromethorphan and Phenylephrine Day time Cold and Flu

Active Ingredient

(in each softgel) of daytime cold and flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

(in each softgel) of nighttime cold and flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 6.25 mg

Purpose

Daytime Cold and Flu:

pain reliever

Cough Suppressant

Nasal decongestant

Nighttime cold and flu purpose:

pain reliever

Cough Suppressant

Antihistamine

Uses

Daytime cold and flu: pain reliever, cough suppressant and Nasal decongestant

NightTime Cold and Flu: pain reliever, cough suppressant and Antihistamine

Warnings

Warnings Failure to follow these warnings could result in serious consequences.

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

do not use:

Ask a doctor before use if you have

ask your 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:

If pregnant or breast-feeding, ask a health professional before use.

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Keep out of reach of children.

If pregnant or breast-feeding, ask a health professional before use.

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Direction

Daytime Cold and Flu:

Other Information

Inactive Ingredients

Daytime:

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

NightTime:

FD&C Blue No.1, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide, glycerin

Questions or Comments

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

f905bb92-figure-01

NDC: 76168-057-12   12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu

DAYTIME NIGHTTIME COLD/FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-057
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-057-121 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 BLISTER PACK
Part 1 of 2
DAYTIME COLD AND FLU 
acetaminophen,dextromethorphan,phenylephrine capsule, liquid filled
Product Information
Item Code (Source)NDC:76168-055
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code 512
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart341
Part 2 of 2
NIGHTTIME COLD AND FLU 
acetaminophen,dextromethorphan,doxylamine capsule, liquid filled
Product Information
Item Code (Source)NDC:76168-056
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
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code 215
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart341
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2014
Labeler - Velocity Pharma (962198409)
Registrant - Velocity Pharma (962198409)

Revised: 7/2014
Document Id: f905bb92-063f-4b40-882d-f2e4514d8d8b
Set id: 9c80c237-6316-4852-a437-480cf4a8997a
Version: 2
Effective Time: 20140731
 
Velocity Pharma