ALLERGY MULTI-SYMPTOM - acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride tablet
Family Dollar

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(s)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Use(s)

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 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.

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
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

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

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 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 caplets every 4 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; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

store at controlled room temperature 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions

Call 1-800-426-9391

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

FAMILY DOLLAR®

NDC 55319-455-08

COMPARE TO THE ACTIVE INGREDIENTS

IN TYLENOL® ALLERGY MULTI-SYMPTOM*

SEE NEW WARNINGS INFORMATION

Allergy

Multi-Symptom

Pain Reliever/Antihistamine/Nasal Decongestant

ACETAMINOPHEN

CHLORPHENIRAMINE MALEATE • PHENYLEPHRINE HCl

Relief of:

Runny Nose, Sneezing

Itchy, Watery Eyes,

Nasal Congestion

Sinus Pain & Pressure

May Cause Drowsiness

with Cool Blast Flavor

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844 REV0810D45508

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.

10401 MONROE ROAD, MATTHEWS, NC 28105 USA

Product Packaging

ALLERGY MULTI-SYMPTOM
acetaminophen, chlorpheniramine maleate and phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55319-455
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
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCRALOSE
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor	MENTHOL	Imprint Code	44;455
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55319-455-08	1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		24 TABLET (24 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (55319-455-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	05/30/2006

Labeler - Family Dollar (024472631)

Revised: 09/2011 Family Dollar