Top Value Effervescent Cold Relief Tablets - Orange

Top Value Effervescent Cold Relief Tablets - Orange
SPL v2
SPL
SPL Set ID c6f207e8-bc0d-853a-e053-2a95a90ac623
Route
ORAL
Published
Effective Date 2021-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (7.8 mg) Aspirin (325 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Acesulfame Aspartame Mannitol Sodium Bicarbonate Docusate Sodium Sodium Benzoate Anhydrous Citric Acid Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: CF Shape: round Color: orange Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-16

Description

(in each effervescent tablet) Aspirin 325 mg (NSAID)* Chlorpheniramine maleate 2 mg Phenylephrine bitartrate 7.8 mg *Nonsteroidal anti-inflammatory drug

Purpose

Aspirin 325 mg (NSAID)*..............................Pain reliever/fever reducer Chlorpheniramine maleate 2 mg...................Antihistamine Phenylephrine Bitartrate 7.8 mg...................Nasal decongestant *Nonsteroidal anti-inflammatory drug


Medication Information

Purpose

Aspirin 325 mg (NSAID)*..............................Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg...................Antihistamine

Phenylephrine Bitartrate 7.8 mg...................Nasal decongestant

*Nonsteroidal anti-inflammatory drug

Description

(in each effervescent tablet) Aspirin 325 mg (NSAID)* Chlorpheniramine maleate 2 mg Phenylephrine bitartrate 7.8 mg *Nonsteroidal anti-inflammatory drug

Uses

■ temporarily relieves these symptoms due to the common cold:

■ sneezing ■ nasal congestion ■ sore throat

■ headache ■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

■ temporarily reduces fever

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53413-1

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

Tower Laboratories LTD

8 Industrial Park Road

Centerbrook, CT 06409

or by calling the following:

1-888-228-6937

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 an 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 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.

Directions

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

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

■ do not take more than 8 tablets in 24 hours

■ children under 12 years: ask a doctor

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. ■ if you ever had an allergic reaction to this product or any of its ingredients.

Other Information

each tablet contains: sodium 464 mg

■ phenylketonurics: contains phenylalanine 9 mg per tablet

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

Active Ingredients

(in each effervescent tablet)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine bitartrate 7.8 mg

*Nonsteroidal anti-inflammatory drug

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, docusate sodium, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

When Using This Product

When using this product do not exceed the recommended dosage

■ 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

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 Before Use If You Have

Ask a doctor before use if you have ■ asthma ■ 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

Package Label.principal Display Panel

Ask A Doctor Or Pharmacist Before Use If You Are

Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers ■ presently taking a prescription drug ■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis


Structured Label Content

Uses

■ temporarily relieves these symptoms due to the common cold:

■ sneezing ■ nasal congestion ■ sore throat

■ headache ■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

■ temporarily reduces fever

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53413-1 (53413-1)

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

Tower Laboratories LTD

8 Industrial Park Road

Centerbrook, CT 06409

or by calling the following:

1-888-228-6937

Purpose

Aspirin 325 mg (NSAID)*..............................Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg...................Antihistamine

Phenylephrine Bitartrate 7.8 mg...................Nasal decongestant

*Nonsteroidal anti-inflammatory drug

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 an 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 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.

Directions

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

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

■ do not take more than 8 tablets in 24 hours

■ children under 12 years: ask a doctor

Do Not Use (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. ■ if you ever had an allergic reaction to this product or any of its ingredients.

Other Information (Other information)

each tablet contains: sodium 464 mg

■ phenylketonurics: contains phenylalanine 9 mg per tablet

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

Active Ingredients (Active ingredients)

(in each effervescent tablet)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine bitartrate 7.8 mg

*Nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, aspartame, docusate sodium, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

When Using This Product (When using this product)

When using this product do not exceed the recommended dosage

■ 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)

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

Stop Use and Ask A Doctor If (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)

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

Ask a doctor before use if you have ■ asthma ■ 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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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

Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers ■ presently taking a prescription drug ■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis


Advanced Ingredient Data


Raw Label Data

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