Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax Day and Night Liquigels UI 1614294 and 1613941

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Do not take these products at the same time.

Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Day PowerMax® Gels

Active ingredients

Active ingredients (in each capsule) Purposes

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

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

Guaifenesin 200 mg…………………………………………..Expectorant

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

Uses

· helps loosen phlegm (mucus) and thin bronchial secretions to rid

the bronchial passageways of bothersome mucus and make coughs

more productive

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

· nasal congestion · sinus congestion and pressure

· minor aches and pains · headache

· cough · sore throat

· temporarily reduces fever

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

● 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 before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● difficulty in urination due to enlargement of the prostate gland

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

chronic bronchitis or emphysema

● cough with excessive phlegm (mucus)

When using this product

When using this product do not exceed recommended dosage

Ask a doctor or pharmacist before use if you are

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

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 fever, rash or headache that lasts.

These could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

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.

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

Other information

· store at 15°- 25°C (59° - 77°F)

Inactive ingredients

Inactive ingredients FD&C red No. 40, gelatin, glycerin, lecithin, medium chain triglycerides, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

SPL UNCLASSIFIED SECTION

Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Night PowerMax® Gels

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule) Purposes

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

Dextromethorphan hydrobromide 10 mg…… ………Cough suppressant

Doxylamine succinate 6.25 mg…………… ………………...Antihistamine

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

Uses

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

· minor aches and pains · headache

· nasal and sinus congestion · cough

· sore throat · runny nose · sneezing

· temporarily reduces fever

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.

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 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

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

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

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

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.

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 Day dose before starting Night product

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

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

directed by a doctor.

· children under 12 years: do not use

Other information

· store at 15° - 25°C (59° - 77°F)

Inactive ingredients

Inactive ingredients D&C yellow No. 10, FD&C blue No. 1, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Package label

NEW

Alka-Seltzer Plus®

MAXIMUM STRENGTH

Cough, Mucus &

Congestion

POWERMAX® GELS

CONCENTRATED FORMULA

DAY NON DROWSY

ACETAMINOPHEN/ Pain Reliever Reducer Dextromethorphan HBr / Cough Suppressant

Guaifenesin / Expectorant Phenyleprine HCl/ Nasal Decongestant

16 LIQUID GELS

NIGHT

ACETAMINOPHEN/ Pain Reliever Reducer Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate/ Antihistamine Phenyleprine HCl/ Nasal Decongestant

8 LIQUID GELS: 24 TOTAL

Nasal/Chest Congestion
Headache, Body Ache, Sore Throat, Fever
Cough
Mucus

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