alka-seltzer plus max strength sinus congestion & pain day & night powermax gels

alka-seltzer plus max strength sinus congestion & pain day & night powermax gels
SPL v7
SPL
SPL Set ID e2877488-3539-cba2-e053-2995a90a6005
Route
oral
Published
Effective Date 2018-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) phenylephrine (5 mg) acetaminophen (325 mg) doxylamine (6.25 mg)
Inactive Ingredients
sodium hydroxide gelatin povidone polyethylene glycol, unspecified sorbitol fd&c yellow no. 6 titanium dioxide potassium aluminum disilicate glycerin water sorbitan shellac d&c yellow no. 10 sodium benzoate

Identifiers & Packaging

Pill Appearance
Imprint: ASP;N Shape: oval Color: orange Color: green Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2018-07-01

Description

Alka-Seltzer Plus® Maximum Strength Sinus Congestion & Pain Day PowerMax® Gels


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.

Active Ingredient

Active ingredients (in each tablet)

Acetaminophen 325 mg…………….……….Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg…………..Cough suppressant

Phenylephrine hydrochloride 5 mg…………………Nasal decongestant

Indications and Usage

Uses

temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal congestion

· sinus congestion and pressure

· temporarily reduces fever

Directions

Directions

do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4 hours

after the last Night dose before starting Day product.

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

every 4 hours. Do not exceed 6 capsules in 12 hours or as directed

by a doctor.

· children under 12 years: do not use

Description

Alka-Seltzer Plus® Maximum Strength Sinus Congestion & Pain Day PowerMax® Gels

Section 42229-5

Alka-Seltzer Plus® Maximum Strength Sinus Congestion & Pain Day PowerMax® Gels

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

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

Section 50568-5

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

Section 50569-3

Ask a doctor before use if

liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough that occurs 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

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

FD&C yellow #6, ferric oxide, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

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.

Section 60561-8

Other information

● store at room temperature. Avoid temperatures above 40ºC (104ºF).

Package Display Label


Structured Label Content

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.

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Acetaminophen 325 mg…………….……….Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg…………..Cough suppressant

Phenylephrine hydrochloride 5 mg…………………Nasal decongestant

Indications and Usage (34067-9)

Uses

temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal congestion

· sinus congestion and pressure

· temporarily reduces fever

Directions

Directions

do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4 hours

after the last Night dose before starting Day product.

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

every 4 hours. Do not exceed 6 capsules in 12 hours or as directed

by a doctor.

· children under 12 years: do not use

Section 42229-5 (42229-5)

Alka-Seltzer Plus® Maximum Strength Sinus Congestion & Pain Day PowerMax® Gels

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

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if

liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough that occurs 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

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)

FD&C yellow #6, ferric oxide, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

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.

Section 60561-8 (60561-8)

Other information

● store at room temperature. Avoid temperatures above 40ºC (104ºF).

Package Display Label


Advanced Ingredient Data


Raw Label Data

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