DAYTIME SINUS RELIEF- acetaminophen and phenylephrine hydrochloride capsule, liquid filled 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)

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 each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever

Nasal decongestant

Uses

temporarily relieves sinus symptoms:

Warnings

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

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
  • difficulty in urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product,

do not exceed recommended dosage

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 care professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose 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.

Directions

 adults and children 12 years of age and over  take 2 softgels with water every 4 hours
 children 4 to under 12 years of age ask a doctor
 children under 4 years of age     do not use

Other information

Inactive ingredients

FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, edible white ink.

Questions or comments?

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

Principal Display Panel

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

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

DAYTIME

Sinus Relief

Liquid Capsules

Non- drowsy

Acetaminophen- Sinus Headache and Pain

Phenylephrine HCl- Sinus Pressure and Congestion

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

Distributed by:

Greenbrier International, INC.

500 Volvo parkway, Chesapeake, VA 23320

PRODUCT OF CANADA

**Product may vary from image shown

Product Label

Assured

Daytime sinus relief liquid capsules

DAYTIME SINUS RELIEF 
acetaminophen and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1100
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 GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code 48A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1100-81 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/09/2013
Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)

Revised: 11/2013
Document Id: e6eebf85-48bf-453d-9f8d-0f13074d0807
Set id: d98419a7-7583-4743-8337-1054850c8275
Version: 1
Effective Time: 20131111
 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)