DayTime Nitetime Sinus Relief by TOP CARE (Topco Associates LLC) Drug Facts

DayTime Nitetime Sinus Relief by

Drug Labeling and Warnings

DayTime Nitetime Sinus Relief by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAYTIME NITETIME SINUS RELIEF- acetaminophen, doxylamine succinate, phenylephrine hcl 
TOP CARE (Topco Associates 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.

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Drug Facts

Active ingredients in Daytime (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Active ingredients in Nighttime (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose for Daytime

Pain reliever

Nasal decongestant

Purpose for Nighttime

Pain reliever

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves nasal and sinus symptoms:
    • sinus pain
    • headache
    • nasal and sinus congestion
    • runny nose and sneezing (Nighttime only)

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours 
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use

  • to make a child sleep (Nighttime only)
  • 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.                 

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product,

do not exceed recommended dosage. In addition, when using Nighttime:

  • 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

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur 
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

  • do not take more than directed (see Overdose warning) 
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve

Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours.

Nighttime: adults and children 12 years and over: take 2 softgels with water every 4 hours.

  • children under 12 years: do not use

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat

Inactive ingredients in Daytime

edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Inactive ingredients in Nighttime

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

When using Daytime and Nighttime products, carefully read the labeling to insure correct dosing

NON-DROWSY Daytime Sinus Relief

PAIN RELIEVER AND NASAL DECONGESTANT

  • Aches: ACETAMINOPHEN, 325 mg
  • Nasal Congestion: Phenylephrine HCl, 5 mg

†Supports Children's Miracle Network Hospitals Helping Local Kids

DAYTIME SOFTGELS

MULTI-SYMPTOM Nitetime Sinus Relief

PAIN RELIEVER, ANTIHISTAMINE, AND NASAL DECONGESTANT

  • Aches: ACETAMINOPHEN, 325 mg
  • Sneezing/Runny Nose: Doxylamine succinate, 6.25 mg
  • Nasal Congestion: Phenylephrine HCl, 5 mg

COMPARE TO VICKS® DAYQUIL® AND NYQUIL® SINEX® LIQUICAPS® active ingredients*

NITETIME SOFTGELS

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® Sinex® LiquiCaps®.

†A portion of the proceeds from this purchase will support the Children's Miracle Network Hospitals.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

1-888-423-0139  topcare@topco.com

Product of Canada

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Acetaminophen 325 mg, Phenylephrine HCl 5 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg

Top Care Daytime and Nitetime Sinus Relief Softgels

DAYTIME NITETIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 36800-102
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 36800-102-481 in 1 CARTON; Type 0: Not a Combination Product01/15/201301/15/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 16 
Part 24 BLISTER PACK 32 
Part 1 of 2
NITETIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hcl capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 47A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/15/201301/15/2020
Part 2 of 2
DAYTIME SINUS RELIEF 
acetaminophen, phenylephrine hcl capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 48A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/15/201301/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/15/201301/15/2020
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 8/2019
 
TOP CARE (Topco Associates LLC)