Allergy and Sinus PE by Meijer Distribution Inc / LNK International, Inc. Meijer 44-462-Delisted

Allergy and Sinus PE by

Drug Labeling and Warnings

Allergy and Sinus PE by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERGY AND SINUS PE MAXIMUM STRENGTH- chlorpheniramine maleate, phenylephrine hcl tablet 
Meijer Distribution 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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Meijer 44-462-Delisted

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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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

NDC: 41250-862-08                               Compare to SUDAFED PE® SINUS + ALLERGY active ingredients*

meijer  

Maximum Strength

Allergy & Sinus PE
Chlorpheniramine maleate Phenylephrine HCl

Antihistamine Nasal Decongestant

Sneezing, Itchy Eyes & Runny Nose
Sinus Pressure & Congestion

24 TABLETS                              Actual Size

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

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com

Meijer 44-462

Meijer 44-462

ALLERGY AND SINUS PE  MAXIMUM STRENGTH
chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41250-862
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;462
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41250-862-081 in 1 CARTON06/09/200503/29/2020
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/09/200503/29/2020
Labeler - Meijer Distribution Inc (006959555)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(41250-862)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(41250-862)

Revised: 10/2017
 
Meijer Distribution Inc