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

DAYTIME NIGHTTIME COLD/FLU by

Drug Labeling and Warnings

DAYTIME NIGHTTIME COLD/FLU by is a Otc medication manufactured, distributed, or labeled by AGILE PHARMACHEM, VELOCITY PHARMA, medgel. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 15 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

• more than 4 doses in 24 hours which is maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

  do not use:

• with any other drug containing acetaminophen (prescription or not prescription). 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
• Heart disease
• Thyroid disease
• Diabetes
• High blood pressure
• Trouble urinating due to enlarged prostate gland

  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:

• Redness or swelling is present
• You get nervous, dizzy or sleepless
• Fever gets worse or lasts more than 3 days
• New symptoms occur
• Symptoms do not get better within 7 days or are accompanied by a fever

  NightTime Cold and Flu: 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

• more than 4 doses in 24 hours which is maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

do not use:

• with any other drug containing acetaminophen (prescription or not prescription). 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
• Heart disease
• Thyroid disease
• Diabetes
• High blood pressure
• Trouble urinating due to enlarged prostate gland

• 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:

• Redness or swelling is present
• You get nervous, dizzy or sleepless
• Fever gets worse or lasts more than 3 days
• New symptoms occur
• Symptoms do not get better within 7 days or are accompanied by a fever

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:

• do not exceed 4 doses per 24 hours
• take only as directed – see overdose warning
• Adults and children 12 years and over: 2 softgels with water every 4 hours
• children under 12 years: ask a doctor
• Children under 4 years: do not use

  NightTime Cold and Flu

• do not exceed 4 doses per 24 hours
• take only as directed – see overdose warning
• Adults and children 12 years and over: 2 softgels with water every 4 hours
• children under 12 years: ask a doctor
• Children under 4 years: do not use

Other Information

• store at controlled temperature of 59°F to 86°F(15°C to 30°C)
• Protect from direct sun light /Moisture/Freezing

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

NDC: 58805-004-12   12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu

NDC: 58805-004-16   12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu

NDC: 58805-004-18   12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME COLD/FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58805-004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58805-004-12	1 in 1 CARTON	08/01/2014
2	NDC: 58805-004-16	1 in 1 CARTON	08/01/2014
3	NDC: 58805-004-18	1 in 1 CARTON	08/01/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	8
Part 2	1 BLISTER PACK	4

Part 1 of 2

DAYTIME COLD AND FLU 
acetaminophen,dextromethorphan,phenylephrine capsule, liquid filled

Product Information
Item Code (Source)	NDC: 76168-055
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	512
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341

Part 2 of 2

NIGHTTIME COLD AND FLU 
acetaminophen,dextromethorphan,doxylamine capsule, liquid filled

Product Information
Item Code (Source)	NDC: 76168-056
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	215
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2014

Labeler - AGILE PHARMACHEM (650687853)

Registrant - VELOCITY PHARMA (962198409)

Establishment
Name	Address	ID/FEI	Business Operations
medgel		677385498	manufacture(58805-004)