Allerfed Cold and Allergy by GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. / LNK International, Inc. Healthcare 44-525

Allerfed Cold and Allergy by

Drug Labeling and Warnings

Allerfed Cold and Allergy by is a Otc medication manufactured, distributed, or labeled by GREAT LAKES WHOLESALE, MARKETING, & SALES, INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERFED COLD AND ALLERGY- chlorpheniramine maleate and phenylephrine hcl tablet 
GREAT LAKES WHOLESALE, MARKETING, & SALES, 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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Healthcare 44-525

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 respiratory allergies:
    • itchy, watery eyes
    • nasal congestion
    • sneezing
    • runny nose
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • 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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis 

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

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

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 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

Principal Display Panel

HEALTHCARE

NDC: 64092-835-24

Allerfed Cold
& Allergy

Chlorpheniramine maleate 4 mg,
Phenylephrine HCl 10 mg
Antihistamine, Nasal Decongestant

Pseudoephedrine FREE

Relieves:
Nasal Congestion
Runny Nose
Sneezing
Itchy, Watery Eyes

One Tablet Dose

24 TABLETS

50844       REV0612D52508
Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
www.glwholesale.com

HEALTHCARE GUARANTEE
If you are not completely satisfied with this product, regardless of reason, return your unused portion to Great Lakes Wholesale for a full refund.

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

Healthcare 44-525

Healthcare 44-525

ALLERFED COLD AND ALLERGY 
chlorpheniramine maleate and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64092-835
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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code 44;525
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64092-835-241 in 1 CARTON07/22/200211/20/2019
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 FINALpart34107/22/200211/20/2019
Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(64092-835)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(64092-835)

Revised: 3/2019
 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.