Alka-seltzer plus severe cough and cold day and night kit

Spl unclassified section

Alka-Seltzer Plus ®Day Severe Cough & Cold Liquid Gels

Drug Facts

Otc - active ingredient section

Otc - purpose section

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

  • 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
  • relieves the impulse to cough to help you get to sleep
  • temporarily reduces fever

Warnings

Liver warning

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

  • more than 10 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

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)

Otc - ask doctor/pharmacist section

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

Otc - when using section

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

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

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
  • 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

Other information

  • store at room temperature. Avoid excessive heat.

Inactive ingredients

FD&C red #40, gelatin, glycerin, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, simethicone, sorbitan, sorbitol, titanium dioxide

Questions or comments?

1-800-986-0369

(Mon-Fri 9AM 5PM EST) or www.alkaseltzerplus.com

Spl unclassified section

Alka-Seltzer Plus ®Night Severe Cough & Cold Liquid Gels

Drug Facts

Otc - active ingredient section

Otc - purpose 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 10 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

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.

Otc - do not use section

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

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

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
  • 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

Other information

  • store at room temperature. Avoid excessive heat.

Inactive ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, simethicone, sorbitan, sorbitol, titanium dioxide

Questions or comments?

1-800-986-0369

(Mon-Fri 9AM - 5PM EST) or www.alkaseltzerplus.com

Spl unclassified section

Distributed by:
Bayer HealthCare LLC

Ingredients and appearance - Product information

Alka-seltzer plus severe cough and cold day and night kit- Acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin, and doxylamine succinate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0280-1187
Route of Administration Oral

Product Characteristics

Color GREEN Score 1
Shape OVAL Size 25 mm
Imprint Code AS;NITE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part343 USA

Labeler - Bayer HealthCare LLC, Consumer Care( 785159372)

Principal display panel - kit carton

New Cough
Co-Pack!

Alka-
Seltzer
PLUS
®

SEVERE COUGH & COLD

NON
DROWSY DAY

Acetaminophen/ Pain reliever-fever reducer
Dextromethorphan hydrobromide / Cough suppressant
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal decongestant

BAYER

Relieves: Mucus Cough
Headache, Fever, Sore Throat
Nasal & Chest Congestion

12LIQUID GELS (Liquid Filled Capsules)

NIGHT

Acetaminophen/ Pain reliever-fever reducer
Dextromethorphan hydrobromide / Cough suppressant
Doxylamine succinate / Antihistamine
Phenylephrine HCl / Nasal decongestant

Relieves: Cough
Nasal Congestion Runny Nose
Headache, Fever, Sore Throat

8LIQUID GELS (Liquid Filled Capsules)