PhysiciansCare Sinus Non-Drowsy

Dosage form: tablet, film coated
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Acme United Corporation
NDC Code: 0924-0133

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.

Active ingredient (in each tablet)

Phenylephrine HCL 10 mg

Purpose

Nasal decongestant

Uses

Temporarily relieves
  • nasal congestion due to the common cold, hay fever ot other respiratory allergies.
  • sinus congestion and pressure
Promotes nasal and/or sinus drainage.

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.


Directions
  • do not use more than directed
Adults and children: (12 years and older)
take 1 tablet every 4 hours
Do not take more than 6 doses in 24 hours.

Children under 12 years: Do not give to children under 12 years of age

Other information

  • read all product information before using
  • store at room temperature 59-86 F (15-30 C)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

carnauba wax*, croscarmellose sodium*, crospovidone*, dicalcium phosphate*, FD and C Red No. 40, FD and C Yellow No. 6, hypromellose, lactose*, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol*, propylene glycol*, silicon dioxide*, starch*, stearic acid*, titanium dioxide, triacetin*.

*may contain

Questions or Comments?

1-800-835-2263

Warnings

Do not use

  • 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 doc tor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
When using this product
  • do not exceed recommended dosage
Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • symptoms do not improve with 7 days or are accompanied by fever
If pregnant or breast-feeding, ask a health professional before use
PHYSICIANSCARE SINUS   NON-DROWSY
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0133(NDC:47682-133)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 2000 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
Product Characteristics
Colorred (red) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code272
Contains    
Packaging
#Item CodePackage Description
1NDC:0924-0133-0150 PACKET (PACKET) in 1 CARTON
11 TABLET, FILM COATED (TABLET) in 1 PACKET
2NDC:0924-0133-0310 PACKET (PACKET) in 1 CARTON
21 TABLET, FILM COATED (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/29/2012
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIOperations
Acme United Corporation045924339relabel, repack
Establishment
NameAddressID/FEIOperations
Acme United Corporation Pac-Kit Safety Division883538258relabel, repack

Revised: 01/2012
 
Acme United Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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