Alka-seltzer Plus Maximum Strength Cough, Mucus & Congestion Liquigels Ui 1614294

Alka-seltzer Plus Maximum Strength Cough, Mucus & Congestion Liquigels Ui 1614294
SPL v5
SPL
SPL Set ID a6a2dd4a-a3c8-2dfa-e053-2995a90ada86
Route
ORAL
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Sorbitan Water Gelatin Medium-chain Triglycerides Povidone Sorbitol Shellac Potassium Aluminum Disilicate Fd&c Red No. 40 Lecithin, Soybean Propylene Glycol Sodium Hydroxide Titanium Dioxide Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: ASP;S Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50567-7

When using this product do not exceed recommended dosage

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

Other Information

Other information

· store at 15° - 25°C (59° - 77°F)

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

Inactive Ingredients

Inactive ingredients FD&C red #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

Questions Or Commens

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

Package Label Carton 24

Ask A Doctor Or Pharmacist

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

Stop Use and Ask A Doctor If

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.

Ask A Doctor Before Use If You Have

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)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

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

Other Information (Other information)

Other information

· store at 15° - 25°C (59° - 77°F)

Active Ingredients (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

Inactive Ingredients (Inactive ingredients)

Inactive ingredients FD&C red #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

Questions Or Commens (Questions or commens)

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

Package Label Carton 24 (Package label carton 24)

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

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

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)

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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)


Advanced Ingredient Data


Raw Label Data

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