Alka-seltzer Plus® Cold Orange Zest Effervescent Tablets

Alka-seltzer Plus® Cold Orange Zest Effervescent Tablets
SPL v7
SPL
SPL Set ID 53188c41-3f13-311b-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2018-09-10
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
Anhydrous Citric Acid Calcium Silicate Fd&c Red No. 40 Sodium Benzoate Acesulfame Potassium Dimethicone Fd&c Yellow No. 6 Docusate Sodium Mannitol Povidone Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: Alka;Seltzer Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-07-15

Description

Active ingredients (in each tablet) Aspirin 325 mg (NSAID)* Chlorpheniramine maleate 2 mg Phenylephrine bitartrate 7.8 mg *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.

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 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.

Do not use to sedate children.

Indications and Usage

Uses

· temporarily relieves these symptoms due to a cold:

· minor aches and pains · headache · runny nose

· nasal and sinus congestion · sneezing · sore throat

· temporarily reduces fever

Dosage and Administration

Directions

● adults and children 12 years and over: take 2 tablets fully dissolved

in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours

or as directed by a doctor.

● children under 12 years: do not use

Description

Active ingredients (in each tablet) Aspirin 325 mg (NSAID)* Chlorpheniramine maleate 2 mg Phenylephrine bitartrate 7.8 mg *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

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

● 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

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

● fever gets worse or lasts more than 3 days

● redness or swelling is present

● new symptoms occur

● ringing in the ears or a loss of hearing occurs

● nervousness, dizziness, or sleeplessness occur

Section 50567-7

When using this product

do not exceed recommended dosage

● excitability may occur, especially in children

● you may get drowsy

● avoid alcoholic drinks

● 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

· taking a prescription drug for

· gout · diabetes · arthritis

· taking sedatives or tranquilizers

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 have

● asthma ● diabetes

● thyroid disease ● glaucoma

● difficulty in urination due to enlargement of the prostate gland

● a breathing problem such as emphysema or chronic bronchitis

● a sodium-restricted diet

Section 50570-1

Do not use

● if you are allergic to aspirin or any other pain reliever/fever reducer

● 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 have ever had an allergic reaction to this product or any of

its ingredients

● in children under 12 years of age

Section 51727-6

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

Section 51945-4

ALka-

Seltzer®

PLUS

Cold

ORANGE ZEST

ASPIRIN (NSAID)/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Phenylephrine Bitartrate/Nasal Decongestant

  • Nasal Congestion
  • Runny Nose
  • Sore Throat
  • Headache & Body Ache
  • Sinus Pressure

20 EFFERVESCENT TABLETS

Section 53413-1

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

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

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

● each tablet contains: sodium 476 mg

● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat.


Structured Label Content

Indications and Usage (34067-9)

Uses

· temporarily relieves these symptoms due to a cold:

· minor aches and pains · headache · runny nose

· nasal and sinus congestion · sneezing · sore throat

· temporarily reduces fever

Dosage and Administration (34068-7)

Directions

● adults and children 12 years and over: take 2 tablets fully dissolved

in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours

or as directed by a doctor.

● children under 12 years: do not use

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.

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 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.

Do not use to sedate children.

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

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

● 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

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

● fever gets worse or lasts more than 3 days

● redness or swelling is present

● new symptoms occur

● ringing in the ears or a loss of hearing occurs

● nervousness, dizziness, or sleeplessness occur

Section 50567-7 (50567-7)

When using this product

do not exceed recommended dosage

● excitability may occur, especially in children

● you may get drowsy

● avoid alcoholic drinks

● 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

· taking a prescription drug for

· gout · diabetes · arthritis

· taking sedatives or tranquilizers

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 have

● asthma ● diabetes

● thyroid disease ● glaucoma

● difficulty in urination due to enlargement of the prostate gland

● a breathing problem such as emphysema or chronic bronchitis

● a sodium-restricted diet

Section 50570-1 (50570-1)

Do not use

● if you are allergic to aspirin or any other pain reliever/fever reducer

● 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 have ever had an allergic reaction to this product or any of

its ingredients

● in children under 12 years of age

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

ALka-

Seltzer®

PLUS

Cold

ORANGE ZEST

ASPIRIN (NSAID)/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Phenylephrine Bitartrate/Nasal Decongestant

  • Nasal Congestion
  • Runny Nose
  • Sore Throat
  • Headache & Body Ache
  • Sinus Pressure

20 EFFERVESCENT TABLETS

Section 53413-1 (53413-1)

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

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)

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

● each tablet contains: sodium 476 mg

● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat.


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Raw Label Data

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