Alka-seltzer Plus Multi-symptom Cold & Flu Day And Night Liquid Gels

Alka-seltzer Plus Multi-symptom Cold & Flu Day And Night Liquid Gels
SPL v7
SPL
SPL Set ID 34b2e77f-5d04-15a7-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2016-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Ferrosoferric Oxide Gelatin Water Shellac Propylene Glycol Glycerin Polyethylene Glycol, Unspecified Povidone Maltodextrin Ascorbic Acid Sunflower Oil .beta.-carotene Medium-chain Triglycerides Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: FR;NC Shape: capsule Color: white Color: yellow Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-07-15 Until 2019-04-30

Description

Alka Seltzer Plus Multi Symptom Cold and Flu Day Liquigels Drug Facts

Purpose

Purposes Pain reliever/fever reducer Cough suppressant Nasal Decongestant


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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.

Purpose

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal Decongestant

Description

Alka Seltzer Plus Multi Symptom Cold and Flu Day Liquigels Drug Facts

Uses

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

Section 42229-5

Alka Seltzer Plus Multi Symptom Cold and Flu Day Liquigels

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away. Quick medical attention

is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

· pain, cough, 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

· cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

Section 50567-7

When using this product

do not exceed recommended dosage

● may cause marked drowsiness

● avoid alcoholic drinks

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in children

Section 50568-5

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes ● glaucoma

● cough with excessive phlegm (mucus)

● a breathing problem such as emphysema or chronic bronchitis

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

Section 50570-1

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.

● 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 acacia gum, ascorbic acid, citric acid,

Dl-alpha-tocopherol, ferrosoferric oxide NF, gelatin, glycerin, maltodextrin, medium chain triglyceride oil, natural beta-carotene, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol-sorbitan solution, sunflower oil

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Section 55106-9

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

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.

● 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

Ask A Doctor

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

Other Information

Other information

· store at room temperature. Avoid excessive heat above 40ºC

(104ºF).

Active Ingredients

Active ingredients

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Inactive Ingredients

Inactive ingredients

ferrosoferric oxide NF, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac purified, sorbitol-sorbitan solution

Questions Or Comments

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

Questions Or Comments?

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

When Using This Product

When using this product do not exceed recommended dosage

Stop Use and Ask A Doctor

Stop use and ask a doctor if

· pain, cough, 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

· cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

If Pregnant Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away. Quick medical attention

is critical for adults as well as for children even if you do not notice any signs or symptoms.


Structured Label Content

Uses

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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 42229-5 (42229-5)

Alka Seltzer Plus Multi Symptom Cold and Flu Day Liquigels

Drug Facts

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. Quick medical attention

is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

· pain, cough, 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

· cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

Section 50567-7 (50567-7)

When using this product

do not exceed recommended dosage

● may cause marked drowsiness

● avoid alcoholic drinks

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in children

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes ● glaucoma

● cough with excessive phlegm (mucus)

● a breathing problem such as emphysema or chronic bronchitis

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

Section 50570-1 (50570-1)

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.

● 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 acacia gum, ascorbic acid, citric acid,

Dl-alpha-tocopherol, ferrosoferric oxide NF, gelatin, glycerin, maltodextrin, medium chain triglyceride oil, natural beta-carotene, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol-sorbitan solution, sunflower oil

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purpose

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal Decongestant

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

Do Not Use (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.

● 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

Ask A Doctor (Ask a Doctor)

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

Other Information (Other information)

Other information

· store at room temperature. Avoid excessive heat above 40ºC

(104ºF).

Active Ingredients

Active ingredients

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Inactive Ingredients

Inactive ingredients

ferrosoferric oxide NF, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac purified, sorbitol-sorbitan solution

Questions Or Comments (Questions or Comments)

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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)

When using this product do not exceed recommended dosage

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

Stop use and ask a doctor if

· pain, cough, 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

· cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away. Quick medical attention

is critical for adults as well as for children even if you do not notice any signs or symptoms.


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