DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

NIGHT TIME SINUS- acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled 
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 (in each softgel)

Acetaminophen 325 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/ fever reducer

Antihistamine

Nasal decongestant

Uses

temporarily relieves nasal & sinus symptoms:

  • sinus pain
  • nasal & sinus congestion
  • headache
  • runny nose and sneezing

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses in 24 hrs, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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

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. Prompt medical attention is critical for adults and for children even if you do not notice any signs or symptoms

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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • glaucoma
  • difficulty in urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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. 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.

Directions

  • take every 4 hours
  • do not take more than 6 doses in 24 hours
  • do not use more than directed (see Overdose warning)
  • when using other night- time and day- time products, carefully read each label to ensure correct dosing
 adults and children 12 years of age and older swallow 2 softgels with water
 children 4 to 12 years of age ask a doctor
 children under 4 years of age do not use

Other information

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

Inactive ingredients

bone gelatin, FD&C Blue No. 1, glycerin USP, polyethylene glycol 400 NF, povidone K12PF, propylene glycol USP, purified water, sorbitol special, and white edible ink.

Principal Display Panel

Multi- Symptom

Night- Time sinus Liquid capsules

Relieves:

Sinus headache

pain

congestion

Acetaminophen, Doxylamine succinate, Phenylephrine HCl

Pain reliever/ fever reducer, antihistamine, nasal decongestant

Distributed by:

Chain Drug Consortium, LLC

2300 NW Corporate blvd., suite 115

Boca Raton, FL 33431

Call toll free 1-877-753-3935

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.

PRINCIPAL DISPLAY PANEL - 24 Capsule Carton

premier value night time sinus

Night time sinus

NIGHT TIME SINUS 
acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68016-101
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 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 47A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68016-101-121 in 1 CARTON07/13/201012/01/2017
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/13/201012/01/2017
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 7/2019