Xl3frteactmnphnchlrphnirmnphnylphrinhclmdway

Xl3frteactmnphnchlrphnirmnphnylphrinhclmdway
SPL v7
SPL
SPL Set ID 58252f15-485c-3061-e053-2a91aa0a2320
Route
ORAL
Published
Effective Date 2017-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (4 mg) Phenylephrine (10 mg)
Inactive Ingredients
Triacetin Lactose Monohydrate Stearic Acid Povidone Hypromelloses Titanium Dioxide Fd&c Yellow No. 5 Water Alcohol

Identifiers & Packaging

Pill Appearance
Imprint: XL3;FORTE Shape: round Color: yellow Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-01

Description

Acetaminophen 325 mg Chlorpheniramine maleate 4 mg Phenylepherine HCl 10 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 4 mg Phenylepherine HCl 10 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 6 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

Alergy 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 (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.

Do Not Use

■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ if you are taking a 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 contasins 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.

Package Label

Other Information

■ store at room temperature 59-86F (15-30C) ■ do not use if package is torn or damaged

Inactive Ingredients

Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive

Questions and Comments?

You may report side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST

When Using This Product

do not use more than directed ■ excitability may occur, especially in children ■ may cause drowsiness ■ 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

■ redness or swelling is present ■ new symptoms occur ■ you get nervous, dizzy, or sleepless ■ pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days

Keep Out of Reach of Children

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 (1-800-222-1222) right away.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask Adoctor Before Use If You Have

■ liver disease ■ heart disease ■ glaucoma ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis

Active Ingredients (in Each Tablet)

Acetaminophen 325 mg

Chlorpheniramine maleate 4 mg

Phenylepherine HCl 10 mg

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 6 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

Alergy 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 (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.

Do Not Use (Do not use)

■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ if you are taking a 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 contasins 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.

Package Label

Other Information

■ store at room temperature 59-86F (15-30C) ■ do not use if package is torn or damaged

Inactive Ingredients

Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive

Questions and Comments?

You may report side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST

When Using This Product (When using this product)

do not use more than directed ■ excitability may occur, especially in children ■ may cause drowsiness ■ 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 (Stop use and ask a doctor if)

■ redness or swelling is present ■ new symptoms occur ■ you get nervous, dizzy, or sleepless ■ pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days

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

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 (1-800-222-1222) right away.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask Adoctor Before Use If You Have (Ask adoctor before use if you have)

■ liver disease ■ heart disease ■ glaucoma ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis

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

Acetaminophen 325 mg

Chlorpheniramine maleate 4 mg

Phenylepherine HCl 10 mg

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

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