Effervescent Cold Relief Tablets

Effervescent Cold Relief Tablets
SPL v4
SPL
SPL Set ID 90622927-9682-4eb0-8c7f-894230b3dda4
Route
ORAL
Published
Effective Date 2014-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: CF Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-01

Description

Active ingredients (in each effervescent tablet)             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

Warnings and Precautions

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. (See note below)

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.

Indications and Usage

Fast Relief of: Nasal Congestion, Runny Nose, Sneezing, Headache, Sinus Pain & Pressure

Dosage and Administration

Directions

■ do not use more than directed 

■ 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

Description

Active ingredients (in each effervescent tablet)             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

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50568-5

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

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

Inactive ingredients:

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

benzoate, sodium bicarbonate

Section 51945-4

Section 53414-9

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.

Section 55105-1

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

Drug Facts

Active ingredients (in each effervescent tablet)             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


Structured Label Content

Indications and Usage (34067-9)

Fast Relief of: Nasal Congestion, Runny Nose, Sneezing, Headache, Sinus Pain & Pressure

Dosage and Administration (34068-7)

Directions

■ do not use more than directed 

■ 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

Warnings and Precautions (34071-1)

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. (See note below)

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients:

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

benzoate, sodium bicarbonate

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

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

Drug Facts

Active ingredients (in each effervescent tablet)             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


Advanced Ingredient Data


Raw Label Data

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