top value effervescent cold relief

top value effervescent cold relief
SPL v5
SPL
SPL Set ID 440a00b1-7960-0cc4-e054-00144ff8d46c
Route
oral
Published
Effective Date 2010-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (325 mg) phenylephrine (7.8 mg) chlorpheniramine (2 mg)
Inactive Ingredients
acesulfame potassium sodium benzoate docusate sodium aspartame sodium bicarbonate anhydrous citric acid mannitol povidone k30

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
otc monograph drug active Since 2010-07-01

Purpose

Pain reliever/fever reducer Antihistamine Nasal decongestant

Description

Pain reliever/fever reducer Antihistamine Nasal decongestant


Medication Information

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Uses

temporarily relieves these symptoms of the common cold

■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache

■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Directions

■ do not use more than directed (see overdose warning)

■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours

■ do not take more than 8 tablets in 24 hours

■ children under 12 years: ask a doctor

Other Information

each tablet contains:

sodium 464 mg

■ phenylketonurics: contains phenylalanine 9 mg per tablet

■ store at room temperature (59°-86°F)

Description

Pain reliever/fever reducer Antihistamine Nasal decongestant

Section 50565-1

Keep out of reach of children.

Section 51945-4

Section 53413-1

Serious side effects associated with the use of this product can be reported to the following address:

Tower Laboratories LTD

P.O. Box 306

8 Industrial Park Road

Centerbrook, CT 06409

Do Not Use

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ if you are allergic to aspirin

■ 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.

Active Ingredients

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine Bitartrate 7.8 mg

*Nonsteroidal anti-inflammatory drug

In Case of Overdose,

get medical help or contact a Poison Control Center right away.

Inactive Ingredients:

acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

When Using This Product

■ do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by doctor.

■ do not use more than directed

■ you may get drowsy

■ avoid alcoholic drinks

■ excitability may occur, especially in children

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

Ask A Doctor Before Use If

■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you are taking sedatives or tranquilizers

You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet

Stop Use and Ask A Doctor If

■ you experience any of the following signs of stomach bleeding

■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better

■ an allergic reaction occurs. Seek medical help right away.

■ pain or nasal congestion gets worse or lasts more than 7 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

■ ringing in the ears or a loss of hearing occurs

■ nervousness, dizziness or sleeplessness occurs

If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Ask A Doctor Or Pharmacist Before Use If You Are

■ presently taking a prescription drug.

■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis


Structured Label Content

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Uses

temporarily relieves these symptoms of the common cold

■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache

■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Directions

■ do not use more than directed (see overdose warning)

■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours

■ do not take more than 8 tablets in 24 hours

■ children under 12 years: ask a doctor

Other Information (Other information)

each tablet contains:

sodium 464 mg

■ phenylketonurics: contains phenylalanine 9 mg per tablet

■ store at room temperature (59°-86°F)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Serious side effects associated with the use of this product can be reported to the following address:

Tower Laboratories LTD

P.O. Box 306

8 Industrial Park Road

Centerbrook, CT 06409

Do Not Use (Do not use)

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ if you are allergic to aspirin

■ 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.

Active Ingredients (Active ingredients)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine Bitartrate 7.8 mg

*Nonsteroidal anti-inflammatory drug

In Case of Overdose, (In case of overdose,)

get medical help or contact a Poison Control Center right away.

Inactive Ingredients:

acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

When Using This Product (When using this product)

■ do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by doctor.

■ do not use more than directed

■ you may get drowsy

■ avoid alcoholic drinks

■ excitability may occur, especially in children

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

Ask A Doctor Before Use If (Ask a doctor before use if)

■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you are taking sedatives or tranquilizers

You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet

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

■ you experience any of the following signs of stomach bleeding

■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better

■ an allergic reaction occurs. Seek medical help right away.

■ pain or nasal congestion gets worse or lasts more than 7 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

■ ringing in the ears or a loss of hearing occurs

■ nervousness, dizziness or sleeplessness occurs

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

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

■ presently taking a prescription drug.

■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis


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