Physicians Care Allergy

Physicians Care Allergy
SPL v12
SPL
SPL Set ID fd101c27-6ba9-4cd3-baec-a354504c37a0
Route
ORAL
Published
Effective Date 2021-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (2 mg) Phenylephrine (5 mg)
Inactive Ingredients
Povidone Cellulose, Microcrystalline Hypromelloses Polyethylene Glycol, Unspecified Starch, Corn Stearic Acid Crospovidone

Identifiers & Packaging

Pill Appearance
Imprint: AZ;275 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-12-23

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

■ more than 4,000 mg of acetaminophen 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.

Indications and Usage

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies

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

Dosage and Administration

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.

Description

Drug Facts

Section 34076-0

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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

■ any new symptoms appear

■ redness or swelling is present

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

Inactive ingredients

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





Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reduecer

Antihistamine

Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Questions?

1-800-835-2263

Allergy Plus Label

90091

Physicians Care®

Allergy Plus

Multi-Symptom Relief

Pull To Open

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)


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

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

■ more than 4,000 mg of acetaminophen 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.

Section 34076-0 (34076-0)

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

■ any new symptoms appear

■ redness or swelling is present

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

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





Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reduecer

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Questions?

1-800-835-2263

Allergy Plus Label

90091

Physicians Care®

Allergy Plus

Multi-Symptom Relief

Pull To Open

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)


Advanced Ingredient Data


Raw Label Data

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