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Name:Allergy Relief
Manufacturer:Meijer Distribution Inc
Category:Over-the-counter (OTC) Marketed Drugs


Meijer Distribution, Inc. Allergy Relief Drug Facts

ALLERGY RELIEF - acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride 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 Distribution, Inc. Allergy Relief Drug Facts

Active ingredient (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 and the common cold:
  • headache
  • sinus congestion and pressure
  • nasal congestion
  • runny nose and sneezing
  • 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

Warnings

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

  • more than 12 caplets 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 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.
  • to make a child sleepy

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

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

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 Liver warning)
adults and children 12 years and over
  • take 2 caplets every 4-6 hours
  • swallow whole – do not crush, chew or dissolve
  • do not take more than 12 caplets in 24 hours
children under 12 years
  • do not use this adult product in children under 12 years of age

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, carnauba wax, flavor, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tylenol® Allergy Multi-Symptom active ingredients

See New Warnings Information

Cool Ice®

Instant Cooling Sensation

Allergy Relief

Multi-Symptom

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl

Pain Reliever, Nasal Decongestant, Antihistamine

Fast Relief of:

Runny Nose

Sneezing

Itchy, Watery Eyes

Nasal Congestion and Sinus Pressure

May Cause Drowsiness

Allergy Relief Carton Image 1

Allergy Relief Carton Image 1

Allergy Relief Carton Image 2

Allergy Relief Carton Image 2


ALLERGY RELIEF 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-476
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM  
CARNAUBA WAX  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POLYVINYL ALCOHOL  
POVIDONE  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE (off white) Score no score
Shape CAPSULE Size 19mm
Flavor VANILLA (Vanilla-menthol) Imprint Code L476
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-476-62 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 12 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (41250-476-62)
2 NDC:41250-476-67 4 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 12 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (41250-476-67)
3 NDC:41250-476-68 3 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
3 12 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (41250-476-68)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/18/2005

Labeler - Meijer Distribution Inc (006959555)

Revised: 10/2009 Meijer Distribution Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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