PHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated

PhysiciansCare Allergy by

Drug Labeling and Warnings

PhysiciansCare Allergy by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Pain reliever/fever reduecer

Antihistamine

Nasal decongestant

Uses

temporarily relievesthese symptoms of hay fver or other respieatory allergies

• nasal congestion
• headache
• itchy, watery eyes
• itchuing of the nose and throat
• running nose and sneezing
• minor aches and pains
• sinus congestion and pressure

Warnings

Liver warning:

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

■ more than 12 tablets 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

Allergy alert:

acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

■ for more than 10 days for pain unless directed by a doctor

■ for more than 3 days for fever unless directed by a doctor

■ with any other drug using the above active ingredients

■ 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

■ thyroid disease

■ diabetes

■ high blood pressure

■ heart disease

■ glaucoma

■ chronic bronchitis or emphysema

■ difficulty in urination due to enlargement of the prostate gland

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives and tranquilizers may increase the drowsiness effect

■ use caution when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

Stop use and ask a doctor if

■ symptoms do not improve within 7 days or are accompanied by a fever

■ pain or fever persists or gets worse

■ redness or swelling is present

■ any new symptoms appear

Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

• store at room temperature 59º-86ºF (15º-30ºC)
• tamper-evident sealed packets
• do not use any opened or torn packets
• avoid excessive heat and humidity

INACTIVE INGREDIENT

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions?

1-800-835-2263

Allergy Plus Label

90091

Physicians Care®

Allergy Plus

Multi-Symptom Relief

This Package For Households Without Young Children

COATED TABLETS

Tamper-Evident Packets of 2 tablets

Do not use if packet is open or torn

100 Tablets (50 Packets, 2 tablets each)

INGREDIENTS AND APPEARANCE

PHYSICIANSCARE ALLERGY  MULTI-SYMPTOM RELIEF
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0091
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
CROSPOVIDONE (UNII: 2S7830E561)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ;275
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0091-01	50 in 1 CARTON	12/23/2011
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/23/2011

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-0091) , repack(0924-0091)