DAY-TIME NIGHT-TIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Day-Time Night-Time by

Drug Labeling and Warnings

Day-Time Night-Time by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients for Night-Time (in each softgel)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15 mg

Doxylamine succinate 6.25 mg

Active ingredients for Day-Time (in each softgel)

Acetaminophen 325 mg, USP

Dextromethorphan Hydrobromide 10 mg

Phenylephrine HCl 5 mg

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• minor aches and pains
• sore throat pain 
• fever
• headache
• muscular aches
• nasal congestion (Day-Time only)
• runny nose and sneezing (Night-Time only)
• cough due to minor throat and bronchial irritation(Night- Time only)

Warnings

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

• more than 6 doses in 24 hours (Night-Time), which is the maximum daily amount
• more than 6 doses in 24 hours (Day-Time), which is the maximum daily amount
• 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, rash, nausea, or vomiting, consult a doctor promptly.

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. 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 children even if you do not notice any signs or symptoms

Do not use

• with other drugs 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

Ask a doctor before using if you have

• liver disease
• heart disease
• asthma
• emphysema
• thyroid disease
• diabetes
• high blood pressure
• cough with excessive phlegm (mucus)
• breathing problems
• chronic bronchitis
• persistent or chronic cough
• cough associated with smoking
• trouble urinating due to enlarged prostate gland
• glaucoma (Night-Time only)

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed, in addition when using Night-Time:
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives and tranquilizers may increase drowsiness
• do not use with other products containing acetaminophen

Stop use and ask a doctor if

• swelling or redness is present
• symptoms do not get better within 7 days or are accompanied by a fever
• you get nervous, dizzy or sleepless
• fever gets worse or lasts more than 3 days
• new symptoms occur
• cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

• take only as recommended (see overdose warning)
• take Night-Time or Day-Time

age	Night-Time	Day-Time
adults and children 12 years of age and older	swallow 2 softgels with water every 6 hours	swallow 2 softgels with water every 4 hours
children 4 to 12 years of age	ask a doctor	ask a doctor
children under 4 years of age	do not use	do not use

• If taking Night-Time and Day-Time softgels limit total to 4 doses per day

Other information

• store at room temperature 15°-30°C (59°-86° F) and avoid excessive heat
• this product does not contain phenylpropanolamine (PPA)
• *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Dayquil® and Vicks® Nyquil®

Inactive ingredients

Night-Time D&C Yellow #10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol 400 NF, *polyethylene glycol (PEG)- 600, povidone, propylene glycol USP, purified water USP, sorbitan, sorbitol and white edible ink. *May also contain

Day-Time *butylated hydroxyanisole, *butylated hydroxytoluene, *carmine, *D&C yellow #10, FD&C Red#40, FD&C yellow #6, gelatin, glycerin USP, *mannitol, polyethylene glycol 400 NF, *polyethylene glycol 600, povidone, propylene glycol USP, purified water USP, *sodium metabisulfite, *sorbitan, *sorbitol, sorbitol special, and white edible ink. *May also contain.

Questions or comments?

call toll free 1-877-753-3935

Principal Display Panel

*Compare to active ingredients in Vicks® Dayquil® & Nyquil®

SEE NEW WARNINGS INFORMATION

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

2300 NW CORPORATE BLVD., SUITE 115

BOCA RATON, FL 33431

Product Label

Multi symptom Day-Time Night-Time

INGREDIENTS AND APPEARANCE

DAY-TIME NIGHT-TIME 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-490

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-490-40	1 in 1 CARTON; Type 0: Not a Combination Product

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

Part 1 of 2

NIGHT-TIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule

Product Information
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POVIDONES (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P30;94A;35A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341

Part 2 of 2

DAY-TIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule

Product Information
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POVIDONES (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE (red)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	P19;95A;36A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/12/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/12/2010

Labeler - Chain Drug Consortium, LLC (101668460)