Alka Seltzer Plus Severe Sinus Cold & Cough

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (250 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)

Inactive Ingredients

Propylene Glycol Water Shellac Sodium Hydroxide Titanium Dioxide Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone

Identifiers & Packaging

Pill Appearance

Imprint: AS;SM Shape: oval Color: red Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-01-28

Medication Information

Description

Active ingredients (in each capsule) Purposes Acetaminophen 250 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine hydrochloride 5 mg Nasal decongestant

Uses

temporarily relieves these symptoms due to a cold:

· nasal congestion

· sinus congestion and pressure

· headache

· minor aches and pains

· cough

· sore throat

temporarily restores freer breathing through the nose
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily reduces fever

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 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 51727-6

FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol-sorbitan solution, titanium dioxide

Section 51945-4

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.

Warnings

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

more than 12 capsules in 24 hours, which is the maximum daily amount for this product
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

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 12 capsules in 24 hours or as directed by a doctor.
children under 12 years: 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

store at 15-25ºC (59-77ºF)

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

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)

Active Ingredients (in Each Capsule)

Active ingredients (in each capsule)	Purposes
Acetaminophen 250 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine hydrochloride 5 mg	Nasal decongestant

Structured Label Content

Uses

temporarily relieves these symptoms due to a cold:

· nasal congestion

· sinus congestion and pressure

· headache

· minor aches and pains

· cough

· sore throat

temporarily restores freer breathing through the nose
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily reduces fever

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 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 51727-6 (51727-6)

FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol-sorbitan solution, titanium dioxide

Section 51945-4 (51945-4)

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.

Warnings

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

more than 12 capsules in 24 hours, which is the maximum daily amount for this product
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

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 12 capsules in 24 hours or as directed by a doctor.
children under 12 years: 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 15-25ºC (59-77ºF)

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

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)

Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))

Active ingredients (in each capsule)	Purposes
Acetaminophen 250 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine hydrochloride 5 mg	Nasal decongestant

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to a cold: · nasal congestion · sinus congestion and pressure · headache · minor aches and pains · cough · sore throat temporarily restores freer breathing through the nose helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever", "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.", "50567-7": "When using this product do not exceed recommended dosage", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "51727-6": "FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol-sorbitan solution, titanium dioxide", "53413-1": "Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Warnings": "Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take more than 12 capsules in 24 hours, which is the maximum daily amount for this product 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": "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 12 capsules in 24 hours or as directed by a doctor. children under 12 years: 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": "store at 15-25ºC (59-77ºF)", "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", "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)", "Active ingredients (in each capsule)": "Active ingredients (in each capsule) Purposes Acetaminophen 250 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine hydrochloride 5 mg Nasal decongestant"}