Allergy Multi-Symptom Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Allergy Multi-Symptom Relief

FRED'S, INC.

Freds 44-559


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylepherine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant 

Allergy Multi-Symptom Relief Uses

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

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 taking 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

  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

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 drinks
  • be careful when driving a motor vehicle or operating machinery
  • drowsiness may occur

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick 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
    (see overdose warning)
  • adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 12 gelcaps in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Allergy Multi-Symptom Relief Other information

  • see end flap for expiration date and lot number
  • store at controlled room temperature 15º to 30ºC (59º-86ºF)

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?

1-888-287-1915

Principal display panel

FRED'S®

SEE NEW WARNINGS INFORMATION

Allergy
Pain Reliever, Nasal Decongestant, Antihistamine

Headache/Sore Throat - Acetaminophen
Sinus Pressure
Nasal Congestion - Phenylephrine HCl
Runny Nose/Sneezing
Itchy, Watery Eyes - Chlorpheniramine maleate

24 Gelcaps

Compare To: The Active Ingredient in TYLENOL® Allergy Multi-Symptom Rapid Release Gels*

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 Tylenol® Allergy Multi-Symptom Rapid Release Gels.
50844      REV1009A55908

Allergy Multi-Symptom Relief
Fred's 44-599

Allergy Multi-Symptom Relief

Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate CAPSULE, GELATIN COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-559
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 5
ferric oxide red
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
titanium dioxide
GELATIN

Product Characteristics

Color Size Imprint Code Shape
YELLOW 19 mm 44;559 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:55315-559-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-03-17


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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