ALLERGY RELIEF MULTISYMPTOM- acetaminophen,chlorpheniramine maleate, phenylephrine hcl tablet, coated

Allergy Relief Multisymptom by

Drug Labeling and Warnings

Allergy Relief Multisymptom by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer
Chlorpheniramine Maleate 2 mg.............................Antihistamine
Phenylephrine HCl 5 mg.............................Nasal Decongestant

PURPOSE

Pain Reliever, Fever Reducer, Antihistamine, Nasal Decongestant

DOSAGE & ADMINISTRATION

Directions: Adults and children 12 years of age and older take 2
tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or
as directed by a doctor Children under 12 years, consult a doctor

INDICATIONS & USAGE

Uses: Temporarily: relieves nasal congestion associated with sinusitis
relieves nasal congestion due to the common cold, hay fever or other
upper respiratory allergies relieves sinus congestion and pressure,
helps decongest sinus openings and passages restores free breathing
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial passages of bothersome mucus, drain bronchial tubes, and
make coughs more productive Temporarily relieves minor aches, pains,
and fever associated with: headache common cold toothache
backache muscular aches menstrual cramps

WARNINGS

Warnings: Liver Warning: This
product contains acetaminophen. Severe liver damage may occur if
you take: more than 8 tablets in 24 hours with other drugs containing
acetaminophen (prescription or nonprescription). Ask a doctor or
pharmacist before using with other drugs if you are not sure. 3 or more
alcoholic drinks every day while using this product Do not: use with
any other product containing acetaminophen this will provide more
than the recommended dose (overdose) of acetaminophen and could
cause serious health concerns. use more than the recommended
dose for more than 10 days for pain unless directed by a doctor for
more than 3 days for fever unless directed by a doctor 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 MAOI drug. If you do not know if your prescription
drug contains an MAOI, consult a doctor or pharmacist before
taking this product. Stop use and ask a doctor if: symptoms
do not improve pain or fever persists or gets worse new
symptoms occur redness or swelling is present nervousness,
dizziness or sleeplessness occur symptoms do not improve within 7
days or are accompanied by fever Ask a doctor before use if you
have: heart disease high blood pressure thyroid disease diabetes
difficulty in urination due to enlargement of the prostate gland a breathing
problem such as emphysema or chronic bronchitis, or if you have glaucoma
or difficulty in urination due to enlargement of the prostate gland may cause
excitability especially in children may cause drowsiness; alcohol, sedatives,
and tranquilizers may increase the drowsiness effect avoid alcoholic
beverages while taking this product do not take this product if you are
taking sedatives or tranquilizers, without first consulting your doctor use
caution when operating machinery.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, ask a health professional
before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENT

Inactive ingredients: FDC Red 40,
Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch
Glycolate, Starch, Stearic Acid

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF MULTISYMPTOM  
acetaminophen,chlorpheniramine maleate, phenylephrine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-457
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K29/32 (UNII: 390RMW2PEQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (FR11)	Size	11mm
Flavor		Imprint Code	FR11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-457-02	2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/15/2012

Labeler - Select Corporation (053805599)