275 - Xl-3 Cold Medicine

275 - Xl-3 Cold Medicine
SPL v5
SPL
SPL Set ID d2762d9c-e7e7-42b2-a26a-14b2aa0307cb
Route
ORAL
Published
Effective Date 2017-01-25
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
Starch, Corn Crospovidone Hypromelloses Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ;275 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-11-15

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Antihistamine Nasal decongestant

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves:

■ minor aches and pains

■ headaches

■ nasal congestion

■ sinus congestion & pressure

■ runny nose

■ sneezing

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

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.

Directions

■ Do not use more than directed

■ Adults and children 12 years of age and older: take 2 tablets every 6 hours.  Do not take more than 12 tablets in 24 hours.

■ Children under 12 years of age: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Do Not Use

■ if you are allergic to acetaminophen

■ more than 10 days 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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Other Information

■ store at room temperature in a dry place

■ do not use if blister package is torn.

Inactive Ingredients

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

Principal Display Panel

XL-3 Cold Medicine
 

Questions and Comments?

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

When Using This Product

■ do not use more than directed

■ excitability may occur, especially in children

■ may cause drowsiness n alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

■ redness or swelling is present  

■ new symptoms occur  

■ you get nervous, dizzy, or sleepless n pain or nasal congestion gets worse or lasts for more than 7 days

■ fever gets worse or lasts for more than 3 days

If Pregnant Or Breast Feeding,

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

Keep Out of Reach of Children.

Keep out of reach of children.  In case of overdose, contact a Poison Control Center (1-800-222-1222) immediately.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Tablet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

■ liver disease

■ heart disease

■ glaucoma

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You

■ are taking the blood thinning drug warfarin

■ are taking sedatives or tranquilizers


Structured Label Content

Uses

temporarily relieves:

■ minor aches and pains

■ headaches

■ nasal congestion

■ sinus congestion & pressure

■ runny nose

■ sneezing

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

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.

Directions

■ Do not use more than directed

■ Adults and children 12 years of age and older: take 2 tablets every 6 hours.  Do not take more than 12 tablets in 24 hours.

■ Children under 12 years of age: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Do Not Use (Do not use)

■ if you are allergic to acetaminophen

■ more than 10 days 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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Other Information (Other information)

■ store at room temperature in a dry place

■ do not use if blister package is torn.

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

XL-3 Cold Medicine
 

Questions and Comments? (Questions and comments?)

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

When Using This Product (When using this product)

■ do not use more than directed

■ excitability may occur, especially in children

■ may cause drowsiness n alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ redness or swelling is present  

■ new symptoms occur  

■ you get nervous, dizzy, or sleepless n pain or nasal congestion gets worse or lasts for more than 7 days

■ fever gets worse or lasts for more than 3 days

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.  In case of overdose, contact a Poison Control Center (1-800-222-1222) immediately.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ liver disease

■ heart disease

■ glaucoma

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)

■ are taking the blood thinning drug warfarin

■ are taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)