ALLERGY MULTI SYMPTOM- acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride tablet 
Kroger Company

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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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

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? 1-800-632-6900

Principal Display Panel

COOL ICE®

INSTANT COOLING SENSATION

COMPARE TO active ingredients of TYLENOL® ALLERGY MULTI-SYMPTOM

See end panel

SEE NEW WARNINGS INFORMATION

May Cause Drowsiness

Allergy Multi-Symptom

Pain Reliever/Nasal Decongestant/Antihistamine

Acetaminophen/Chlorpheniramine Maleate/Phenylephrine HCl

Headache/Sinus Pressure

Nasal Congestion

Runny Nose/Sneezing

Itchy, Watery eyes

Allergy Multi-Symptom Carton Image 1

Allergy Multi-Symptom Carton Image 1

Allergy Multi-Symptom Carton Image 2

Allergy Multi-Symptom Carton Image 2

ALLERGY  MULTI SYMPTOM
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-476
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
ACESULFAME POTASSIUM 
CARNAUBA WAX 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (off white) Scoreno score
ShapeCAPSULESize19mm
FlavorVANILLA (Vanilla-menthol) Imprint Code L476
Contains    
Packaging
#Item CodePackage Description
1NDC:30142-476-622 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/21/2006
Labeler - Kroger Company (006999528)

Revised: 10/2009
 
Kroger Company