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SPL v6
SPL
SPL Set ID da5b31dd-becd-471a-9392-d0ee4b8f9539
Route
ORAL
Published
Effective Date 2011-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg) Dextromethorphan (10 mg)
Inactive Ingredients
D&c Red No. 33 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol 600 Polyethylene Glycol 1000 Povidone Propylene Glycol Water

Identifiers & Packaging

Pill Appearance
Imprint: Xtra Shape: capsule Color: blue Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-11-15 Until 2018-10-15

Description

Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg Dextromethorphan Hydrobromide 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Antihistamine Antitussive Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Antihistamine

Antitussive

Nasal decongestant

Description

Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg Dextromethorphan Hydrobromide 10 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves: • muscular aches and pains • headache • temporarily reduces fever • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies • pressure • nasal congestion • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

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 (see overdose warning) •do not take this product form more than 10 days unless directed by a doctor • Adults and children 12 years of age and over • take 2 capsule every 4 hours. • Do not take more than 12 capsules in 24 hours Children under 12 years of age • Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdoes) may cause liver damage. Do not exceed recommended dosage

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 •if you are allergic to acetaminophen or any of the inactive ingredients in this product

• 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 • for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor • if you are taking sedatives or tranquilizers, without first consulting your doctor.

Package Label

Other Information

Store at room temperature to 15º-30ºC (59º-86ºF) • do not use if package is torn or damaged

Inactive Ingredients

D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, purified water

Questions and Comments?

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

When Using This Product

• excitability may occur, especially in children • may cause drowsiness •alcohol, sedatives and tranquilizers may increase drowsiness effect • use caution when driving a motor vehicle or operating machinery • avoid alcohlic beverages

Stop Use and Aska Doctor

• symptoms do not improve • pain, nasal congestion or cough gets worse or lasts more than 7 days • redness or swelling is present • new symptoms occur •cough comes back or occurs with a rash or a headache tha lasts. These could be the signs of a serious condition • nervousness, dizziness, or sleeplessness occur • 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 the 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 A Doctor Before Use If You Have

• liver disease • a breathing problem such as emphysema • glaucoma • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

Active Ingredients (in Each Capsule)

Acetaminophen 250 mg

Chlorpheniramine Maleate 2 mg

Dextromethorphan Hydrobromide 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You

• are taking the blood thinning drug warfarin


Structured Label Content

Uses

temporarily relieves: • muscular aches and pains • headache • temporarily reduces fever • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies • pressure • nasal congestion • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Purpose

Pain reliever/fever reducer

Antihistamine

Antitussive

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 (see overdose warning) •do not take this product form more than 10 days unless directed by a doctor • Adults and children 12 years of age and over • take 2 capsule every 4 hours. • Do not take more than 12 capsules in 24 hours Children under 12 years of age • Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdoes) may cause liver damage. Do not exceed recommended dosage

Do Not Use (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 •if you are allergic to acetaminophen or any of the inactive ingredients in this product

• 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 • for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor • if you are taking sedatives or tranquilizers, without first consulting your doctor.

Package Label

Other Information (Other information)

Store at room temperature to 15º-30ºC (59º-86ºF) • do not use if package is torn or damaged

Inactive Ingredients (Inactive ingredients)

D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, purified water

Questions and Comments?

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

When Using This Product (When using this product)

• excitability may occur, especially in children • may cause drowsiness •alcohol, sedatives and tranquilizers may increase drowsiness effect • use caution when driving a motor vehicle or operating machinery • avoid alcohlic beverages

Stop Use and Aska Doctor (Stop use and aska doctor)

• symptoms do not improve • pain, nasal congestion or cough gets worse or lasts more than 7 days • redness or swelling is present • new symptoms occur •cough comes back or occurs with a rash or a headache tha lasts. These could be the signs of a serious condition • nervousness, dizziness, or sleeplessness occur • 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 the 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 A Doctor Before Use If You Have (Ask a doctor before use if you have)

• liver disease • a breathing problem such as emphysema • glaucoma • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))

Acetaminophen 250 mg

Chlorpheniramine Maleate 2 mg

Dextromethorphan Hydrobromide 10 mg

Phenylephrine HCl 5 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


Advanced Ingredient Data


Raw Label Data

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