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Allergy Multi-Symptom by FRED'S, INC.

Medically reviewed on August 16, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: FRED'S, INC.
NDC Code: 55315-559

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.

Freds Pharmacy 44-559

Active ingredients (in each gelcap)

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:
    • runny nose and sneezing
    • nasal congestion
    • minor aches and pains
    • headache
    • 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 in 24 hours, which is the maximum daily amount
  • 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:

  • skin reddening
  • blisters
  • rash

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
  • a breathing problem such as emphysema or chronic bronchitis
  • high blood pressure
  • heart disease
  • diabetes
  • liver disease
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
  • thyroid 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
  • may cause drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages

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 gelcaps every 4 hours
    • do not take more than 10 gelcaps in 24 hours
  • children under 12 years: ask a doctor

Other information
  • avoid high humidity
  • contains FD&C Yellow #5 (tartrazine) as a color additive
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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, crospovidone, FD&C red #3, FD&C red #40, FD&C yellow #5, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

fred's
Pharmacy

NDC 55315-559-08

ALLERGY
MULTI-SYMPTOM

Acetaminophen
Chlorpheniramine maleate
Phenylephrine HCl

Pain Reliever, Antihistamine, Nasal Decongestant

NDC 55315-559-08

■ Headache   ■ Sinus Pressure    ■ Nasal Congestion
■ Runny Nose & Sneezing    ■ Itchy, Watery Eyes

Rapid Release Gelcaps

24 GELCAPS

Compare to the active ingredients in:
Tylenol® Allergy
Multi-Symptom*

TAMPER EVIDENT: DO NOT USE IF PACKAGE 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
Tylenol® Allergy Multi-Symptom.  50844          REV0216C55908

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100%
satisfaction
guaranteed

Questions or comments: 1-855-331-FRED (3733)

Freds Pharmacy 44-559

ALLERGY MULTI-SYMPTOM 
acetaminophen, phenylephrine hcl, chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-559
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
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 5 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
TITANIUM DIOXIDE 
GELATIN 
CROSPOVIDONE, UNSPECIFIED 
FD&C RED NO. 3 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
ColorYELLOW, REDScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;9
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-559-082 BLISTER PACK in 1 CARTON
112 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/17/2008
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-559)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55315-559)

 
FRED'S, INC.

← See all Allergy Multi-Symptom brands

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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