Alka-Seltzer Plus Severe Sinus and Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Alka-Seltzer Plus Severe Sinus and Cold

Bayer HealthCare Consumer Care

Alka-Seltzer Plus Severe Sinus & Cold Powder


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Chlorpheniramine maleate 4 mg Antihistamine
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant

Alka-Seltzer Plus Severe Sinus and Cold Uses

  • temporarily relieves these symptoms due to a cold:
    • nasal congestion
    • sinus congestion and pressure
    • minor aches and pains
    • headache
    • cough
    • sore throat
  • temporarily restores freer breathing through the nose
  • helps clear nasal passages; shrinks swollen membranes
  • temporarily reduces fever
  • temporarily relieves these symptoms due to hay fever or other respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes

Warnings

Liver warning

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

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

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

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 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

Alka-Seltzer Plus Severe Sinus and Cold Other information

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

Inactive ingredients

acesulfame potassium, anhydrous citric acid, compressible sugar, dental-type silica, FD&C blue #1, FD&C red #40, flavors, pregelatinized starch, sodium citrate, sucralose, tartaric acid, tribasic calcium phosphate

Questions or comments?

1-800-986-0369

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

NEW!

OFFICIAL SPONSOR

Alka-
Seltzer
PLUS
®

Acetaminophen / Pain
reliever-fever reducer
Chlorpheniramine maleate / Antihistamine
Phenylephrine HCI / Nasal decongestant
Dextromethorphan HBr / Cough
suppressant

Berry Fusion
Fast Relief Mix-In Packets

SEVERE
SINUS &
COLD

• Sinus & Nasal Congestion • Headache
• Sinus Pressure • Cough • Runny Nose
• Body Ache • Sore Throat

6 PACKETS

Alka-Seltzer Plus Severe Sinus and Cold

Alka-Seltzer Plus Severe Sinus and Cold

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0280-0923
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
SODIUM CITRATE
Sucralose
tartaric acid
TRIBASIC CALCIUM PHOSPHATE

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 PACKET
2 NDC:0280-0923-06 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-04-17


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Be sure to consult your doctor before taking any medication!
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