DAYTIME NIGHTTIME COLD/FLU RELIEF A P J- daytime nighttime cold/flu relief kit

DAYTIME NIGHTTIME COLD/FLU RELIEF by

Drug Labeling and Warnings

DAYTIME NIGHTTIME COLD/FLU RELIEF by is a Otc medication manufactured, distributed, or labeled by A P J Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PART 1 OF 2 DAYTIME COLD AND FLU RELIEF

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Phenylephrine HCl 5 mg

PART 2 OF 2 NIGHTTIME COLD AND FLU RELIEF

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Chlorpheniramine Maleate 6.25 mg

PURPOSE

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Keep out of reach of children

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

USES

Temporarily relieves common cold/flu symptoms:

cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
runny nose and sneezing (Nighttime only)
nasal congestion (Daytime only)

WARNINGS

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

more than 4 doses in 24 hours, which is the maximum daily amount for these products

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using these products

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.

to make a child sleep (Nighttime only)

DIRECTIONS

take only as directed – see Overdose warning

take Nighttime OR Daytime.

Nighttime tablets

do not exceed 4 doses per 24 hours

 adults and children 12 years and over  swallow 2 softgels with water every 6 hrs

 children 4 to under 12 years  ask a doctor

 children under 4 years  do not use

DayTime tablets

do not exceed 4 doses per 24 hours

 adults and children 12 years and over  swallow 2 softgels with water every 4 hrs

 children 4 to under 12 years  ask a doctor

 children under 4 years  do not use

when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

INACTIVE INGREDIENT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

STARCH, CORN

BUTYLATED HYDROXYTOLUENE

METHYLPARABEN

PROPYLPARABEN

SODIUM STARCH GLYCOLATE TYPE A POTATO

TALC

MAGNESIUM STEARATE

SILICON DIOXIDE

CROSCARMELLOSE SODIUM

SODIUM LAURYL SULFATE

ISOPROPYL ALCOHOL

METHYLENE CHLORIDE

FD and C YELLOW NO. 6

HYPROMELLOSES

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME COLD/FLU RELIEF  A P J
daytime nighttime cold/flu relief kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46084-121

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46084-121-01	1 in 1 PACKAGE

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	20
Part 2	1 BLISTER PACK	20

Part 1 of 2

DAYTIME COLD/FLU RELIEF  A P J
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet

Product Information
Item Code (Source)	NDC: 46084-122
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)	30 mg
STARCH, CORN (UNII: O8232NY3SJ)	12 mg
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)	.5 mg
METHYLPARABEN (UNII: A2I8C7HI9T)	.8 mg
PROPYLPARABEN (UNII: Z8IX2SC1OH)	.4 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)	8 mg
TALC (UNII: 7SEV7J4R1U)	6 mg
MAGNESIUM STEARATE (UNII: 70097M6I30)	6 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	2 mg
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)	3 mg
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	2 mg
ISOPROPYL ALCOHOL (UNII: ND2M416302)	10 mg
METHYLENE CHLORIDE (UNII: 588X2YUY0A)	20 mg
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)	2 mg
HYPROMELLOSES (UNII: 3NXW29V3WO)	3 mg

Product Characteristics
Color	pink (LIGHT YELLOWISH PINK)	Score	2 pieces
Shape	OVAL (CAPSULE)	Size	20mm
Flavor		Imprint Code	425mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46084-122-20	20 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2013

Part 2 of 2

NIGHTTIME COLD/FLU RELIEF  A P J
acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate tablet

Product Information
Item Code (Source)	NDC: 46084-123
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
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)	30 mg
STARCH, CORN (UNII: O8232NY3SJ)	12 mg
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)	.5 mg
METHYLPARABEN (UNII: A2I8C7HI9T)	.8 mg
PROPYLPARABEN (UNII: Z8IX2SC1OH)	.4 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)	8 mg
TALC (UNII: 7SEV7J4R1U)	6 mg
MAGNESIUM STEARATE (UNII: 70097M6I30)	6 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	2 mg
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)	3 mg
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	2 mg
ISOPROPYL ALCOHOL (UNII: ND2M416302)	10 mg
METHYLENE CHLORIDE (UNII: 588X2YUY0A)	20 mg
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)	2 mg
HYPROMELLOSES (UNII: 3NXW29V3WO)	3 mg

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL (CAPSULE)	Size	20mm
Flavor		Imprint Code	425mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46084-123-20	20 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2013

Labeler - A P J Laboratories Limited (677378339)

Registrant - A P J Laboratories Limited (677378339)

Establishment
Name	Address	ID/FEI	Business Operations
A P J Laboratories Limited		677378339	manufacture(46084-121)