NIGHTTIME SINUS (ACETAMINOPHEN, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]

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  • NIGHTTIME SINUS (ACETAMINOPHEN, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]

NIGHTTIME SINUS (ACETAMINOPHEN, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]
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NDC 50804-101-24
Set ID 5c421f71-38f0-4215-8d73-f759888b9b6b
Category HUMAN OTC DRUG LABEL
Packager Good Sense (Geiss, Destin & Dunn, Inc.)
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Doxylamine Succinate 6.25 mg

    Phenylephrine HCl 5 mg

    Purpose

    Pain reliever

    Antihistamine

    Nasal decongestant

  • Uses

    • temporarily relieves nasal and sinus symptoms:
      • sinus pain
      • headache
      • nasal and sinus congestion 
      • runny nose and sneezing
  • Warnings

    Liver warning: This product contains 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
    • 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
    • trouble 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
    • 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
    • adults and children 12 years and over: take 2 softgels with water every 4 hours
    • swallow whole; do not crush, chew, or dissolve
    • children under 12 years: do not use
    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
  • Other information

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

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

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Pseudoephedrine Free Formula

    Nighttime SINUSLiquid Capsules

    Acetaminophen, Doxylamine Succinate, Phenylephrine HCl Multi-Symptom

    Relieves:

    • Sinus Headache
    • Sinus Pain
    • Runny Nose
    • Sneezing
    • Congestion

    Softgels

    *Compare to active ingredients in Vicks® NyQuil® Sinex® LiquiCaps®

    Distributed by: Geiss, Destin & Dunn Inc.

    Peachtree City, GA 30269

    www.valuelabels.com

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

    Product of Canada

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

  • Product Label

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

    Good Sense Nighttime Sinus Softgel

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SINUS 
    acetaminophen, doxylamine succinate and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-101
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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:50804-101-242 in 1 CARTON07/01/201212/30/2021
    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 FINALpart34107/01/201212/30/2021
    Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)
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