Alka-Seltzer Plus Fast Packs Cold and Flu Formula description, usages, side effects, indications, overdosage, supplying and lots more!

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Alka-Seltzer Plus Fast Packs Cold and Flu Formula

Bayer Corporation Consumer Care Division

Alka-Seltzer Plus


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

Alka-Seltzer Plus Fast Packs Cold and Flu Formula Uses

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • nasal and sinus congestion
    • runny nose
    • sneezing
    • sore throat
  • temporarily reduces fever

Warnings

Liver warning

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

  • more than 5 powder 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.
  • in children under 12 years of age

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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
  • excitability may occur, especially in children
  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • pain 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
  • 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

  • adults and children 12 years and over:
    • dissolve contents of 1 powder packet in 6-8 ounces of hot or cold beverage: juice, tea, black coffee, or water
    • consume entire beverage within 15 minutes
  • take every 4 hours as needed
  • do not exceed 5 powder packets in 24 hours
  • children under 12 years: do not use

Alka-Seltzer Plus Fast Packs Cold and Flu Formula Other information

  • Phenylketonurics: Contains Phenylalanine 6 mg per powder packet
  • store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavor, povidone, sucralose, sucrose

Questions or comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com

Distributed by:
Bayer HealthCare LLC
P.O. Box 1910
Morristown, NJ 07962-1910 USA

PRINCIPAL DISPLAY PANEL - 10 Single Dose Powder Packet Carton

FAST POWDER PACKS

FIZZ-FREE, TASTE-FREE
IN MOST BEVERAGES

Alka-Seltzer
Plus

COLD & FLU
formula

Nasal Congestion - Runny Nose
Headache + Body Ache - Sore Throat
Sinus Pressure

BAYER

10
SINGLE DOSE
POWDER PACKETS

Alka-Seltzer Plus Fast Packs Cold and Flu Formula

Alka-Seltzer Plus Fast Packs Cold and Flu Formula

Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride GRANULE, EFFERVESCENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0280-7190
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
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Product Characteristics

Color
WHITE (White powder)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0280-7190-10 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-08-01


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Be sure to consult your doctor before taking any medication!
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