DAY-TIME NIGHT-TIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 
Chain Drug Consortium, LLC

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.

----------

DRUG FACTS

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:

Warnings

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

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

 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

Other information

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

Premier value day-time night-time softgels 40 count

Multi symptom Day-Time Night-Time

DAY-TIME NIGHT-TIME 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-490
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-490-401 in 1 CARTON; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 20 
Part 22 BLISTER PACK 20 
Part 1 of 2
NIGHT-TIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule
Product Information
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 HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code P30;94A;35A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart341
Part 2 of 2
DAY-TIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
Product Information
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 HYDROBROMIDE15 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (red) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code P19;95A;36A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/12/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/12/2010
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 10/2015
Document Id: a5f7df75-8711-41fe-9b66-b43767c89240
Set id: 40033873-4d75-407d-a9a4-851216178c0e
Version: 3
Effective Time: 20151026
 
Chain Drug Consortium, LLC