FDA Label for Alka-seltzer Plus Day And Night Severe Cold And Flu

View Indications, Usage & Precautions

Alka-seltzer Plus Day And Night Severe Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Alka-Seltzer Plus ^®
Severe Cold + Flu Day

Drug Facts

Alka-Seltzer Plus ^®
Severe Cold + Flu Night

Drug Facts

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

Otc - Purpose

Active ingredients (in each packet)	Purposes
Acetaminophen 500 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant
Phenylephrine hydrochloride 10 mg	Nasal decongestant

Active ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine
Phenylephrine hydrochloride 10 mg	Nasal decongestant

Uses

temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- sore throat
- cough
- nasal congestion
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
- temporarily reduces fever

Liver Warning

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

more than 6 packets 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

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

more than 5 packets 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

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

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)

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

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product do not exceed recommended dosage

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

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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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
take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
children under 12 years: do not use

do not take more than the recommended dose
take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
children under 12 years: do not use

Other Information

each packet contains: potassium 5 mg and sodium 6 mg
store at room temperature

each packet contains: potassium 5 mg and sodium 5 mg
store at room temperature

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, maltodextrin, povidone, pregelatinized starch, silicon dioxide, sodium citrate, stearic acid, sucralose, tartaric acid, tribasic calcium phosphate

acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, pregelatinized starch, sodium citrate, sucralose, tartaric acid, tribasic calcium phosphate

Questions Or Comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

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

Principal Display Panel - Kit Carton

Alka-Seltzer
PLUS ^®

SEVERE COLD + FLU

Honey Lemon Zest
Fast Relief Mix-In Packets

DAY

Acetaminophen / Pain reliever-fever reducer

Phenylephrine HCl / Nasal decongestant

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant

• Nasal Congestion

• Headache & Body Ache
• Cough • Sore Throat• Mucus

• Fever •Chest Congestion

NIGHT

Acetaminophen / Pain reliever-fever reducer

Doxylamine succinate / Antihistamine

Phenylephrine HCl / Nasal decongestant

Dextromethorphan HBr / Cough suppressant