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Complete Allergy and Sinus Multi Symptom

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
NDC Code: 64092-865

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.

Healthcare 44-455C

Active ingredients (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg 

Purpose

Pain reliever
Antihistamine
Nasal decongestant

Uses
  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • headache
    • nasal congestion
    • runny nose and sneezing
    • minor aches and pains
    • sinus congestion and pressure
  • temporarily relieves these additional symptoms of hay fever:
    • itchy, watery eyes
    • itching of the nose or throat
  • helps clear nasal passages
  • helps decongest sinus openings and passages 

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

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.

  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
  • high blood pressure
  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease
  • thyroid disease
  • diabetes
  • liver disease

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers 

When using this product
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • may cause drowsiness

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

HEALTHCARE
NDC 64092-865-24

Complete
Allergy & Sinus

Multi-Symptom CAPLETS

Acetaminophen 325 mg,
Chlorpheniramine maleate 2 mg,
Phenylephrine HCl 5 mg

Relieves:
• Headache • Sinus Pressure
• Nasal Congestion • Runny Nose
• Sneezing • Itchy, Watery Eyes

Pain Reliever, Antihistamine,
Nasal Decongestant

Pseudoephedrine FREE

24 COOL CAPLETS
with Cool Blast Flavor

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

50844       REV0818G45508

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

HEALTH CARE 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

Healthcare 44-455C-AMS

COMPLETE ALLERGY AND SINUS  MULTI SYMPTOM
acetaminophen, chlorpheniramine maleate and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-865
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCRALOSE 
TITANIUM DIOXIDE 
STARCH, CORN 
CROSPOVIDONE 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE 
SILICON DIOXIDE 
TALC 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code44;455
Contains    
Packaging
#Item CodePackage Description
1NDC:64092-865-242 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/28/2005
Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(64092-865)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(64092-865)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(64092-865)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(64092-865)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(64092-865)

 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Medically reviewed on Oct 17, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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