Alka-seltzer Plus ®

Alka-seltzer Plus ®
SPL v8
SPL
SPL Set ID c7a4e6ad-7315-47bf-ae91-cc511da73734
Route
ORAL
Published
Effective Date 2017-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg) Doxylamine (650 mg)
Inactive Ingredients
Starch, Corn Honey Acesulfame Potassium Anhydrous Citric Acid D&c Yellow No. 10 Fd&c Red No. 40 Maltodextrin Povidone Silicon Dioxide Trisodium Citrate Dihydrate Stearic Acid Sucralose Tartaric Acid Tribasic Calcium Phosphate Sucrose Menthol Lemon

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-07-01 Until 2020-03-31
Description

Alka-Seltzer Plus ® Severe Cold + Flu Day Drug Facts

Medication Information

Description

Alka-Seltzer Plus ® Severe Cold + Flu Day Drug Facts

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
Section 42229-5

Alka-Seltzer Plus ®

Severe Cold + Flu Day

Drug Facts

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 53414-9

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

Section 55105-1
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
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 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
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
Other Information
  • each packet contains: potassium 5 mg and sodium 6 mg
  • store at room temperature
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.

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

Questions Or Comments?

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

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
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)
Principal Display Panel Kit Carton

Alka-Seltzer

PLUS ®

SEVERE COLD + FLU

Honey Lemon Zest

Fast Relief Mix-In Packets

DAY NON-DROWSY

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

• Nasal Congestion

• Headache & Body Ache

• Cough • Runny Nose

• Fever • Sore Throat

6 DAY PACKETS + 6 NIGHT PACKETS



12 TOTAL

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

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
Section 42229-5 (42229-5)

Alka-Seltzer Plus ®

Severe Cold + Flu Day

Drug Facts

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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
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
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 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
Liver Warning (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
Other Information (Other information)
  • each packet contains: potassium 5 mg and sodium 6 mg
  • store at room temperature
Sore Throat Warning (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.

Inactive Ingredients (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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (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 (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
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)
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

Alka-Seltzer

PLUS ®

SEVERE COLD + FLU

Honey Lemon Zest

Fast Relief Mix-In Packets

DAY NON-DROWSY

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

• Nasal Congestion

• Headache & Body Ache

• Cough • Runny Nose

• Fever • Sore Throat

6 DAY PACKETS + 6 NIGHT PACKETS



12 TOTAL

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
  • taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:40.678390 · Updated: 2026-03-14T23:02:21.986500