ALLERGY MULTI SYMPTOM - acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride tablet 
Western Family Foods Inc

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Western Family Multi-Symptom Allergy 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

Principal Display Panel

May Cause Drowsiness

See new warnings information

Aspirin Free

Multi-Symptom

Allergy

Pain Reliever, Nasal Decongestant, Antihistamine

Headache – Acetaminophen

Sinus Pressure & Nasal Congestion – Phenylephrine HCl

Runny Nose/Sneezing & Itchy, Watery Eyes – Chlorpheniramine Maleate

Gluten Free

Cool Ice®

Instant Cooling Sensation

Caplets

Compare to Tylenol® Allergy Multi-Symptom active ingredients

ALLERGY  MULTI SYMPTOM acetaminophen, chlorpheniramine maleate, phenylephrine hcl   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 55312-476 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 # NDC Package Description Multilevel Packaging 1 55312-476-62 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 12 TABLET In 1 BLISTER PACK This package is contained within the CARTON (55312-476-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/11/2006

Labeler - Western Family Foods Inc (192166072)

Revised: 10/2009Western Family Foods Inc