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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

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


Medication Information

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.

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

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

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

Description

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

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

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

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.

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

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

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

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

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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