DAYTIME SINUS RELIEF- acetaminophen, phenylephrine hcl capsule, liquid filled 
Robinson Pharma, 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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DayTime Sinus Relief

DayTime Sinus Relief

Active Ingredients (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Nasal decongestant

Uses

temporarily relieves sinus symptoms:

  • sinus pain
  • headache
  • nasal and sinus congestion

Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or mote alcoholic drinks daily while using this product


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
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product do not use more than directed.


Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • symptoms do not improve within 7 days or are accompanied by a fever
  • you get nervous, dizzy or sleepless

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

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

Directions

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs


adults and children 12 yrs and over
2 softgels with water every 4 hrs
chldren 4 to under 12 yrsask doctor
children under 4 yrsdo not use

Other Information

Store at room temperature

Inactive Ingredients

FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

DayTime Sinus Relief 24 Softgels (59995-006-00)

DayTimeLabel
DAYTIME SINUS RELIEF 
acetaminophen, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59995-006
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)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (Light Orange Transparent) Scoreno score
ShapeOVAL (Oblong) Size20mm
FlavorImprint Code RPDS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59995-006-002 in 1 BOX06/12/201306/12/2013
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 finalpart34106/12/201306/12/2013
Labeler - Robinson Pharma, Inc. (831560578)

Revised: 1/2017
Document Id: 476621dc-4a77-732f-e054-00144ff88e88
Set id: 7fbd20bd-8279-4cf5-a063-b4d2a17f99dc
Version: 2
Effective Time: 20170131
 
Robinson Pharma, Inc.