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Sinus and Allergy Maximum Strength

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 4mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Chain Drug Consortium
NDC Code: 68016-687

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.

Premier Value 44-462

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg

Purpose

Antihistamine
Nasal decongestant

Uses
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat 
    • itchy, watery eyes
    • sinus congestion and pressure
    • nasal congestion

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 doctor before use if you have
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use this product in children under 12 years of age

Other information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

Premier
Value®

NDC 68016-687-24

*COMPARE TO THE ACITVE INGREDIENTS IN
  SUDAFED PE® SINUS + ALLERGY 

Maximum Strength

Sinus & Allergy

Chlorpheniramine maleate 4 mg - ANTIHISTAMINE
Phenylephrine HCl 10 mg - NASAL DECONGESTANT

• Sneezing
• Itchy eyes
• Runny nose
• Sinus pressure + congestion

24 Tablets

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Sinus + Allergy.
50844         ORG061246208

DISTRIBUTED BY: CHAIN CONSORTIUM, LLC
UPARC, BLDG. A3, SUITE 338
1020 WILLIAM PITT WAY
PITTSBURGH, PA 15238
www.chaindrugconsortium.com

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Premier Value 44-462

SINUS AND ALLERGY  MAXIMUM STRENGTH
chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-687
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint Code44;462
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-687-241 BLISTER PACK in 1 CARTON
124 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/09/2005
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(68016-687)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(68016-687)

Revised: 06/2016
 
Chain Drug Consortium

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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