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Name:Alka-seltzer Plus Fast Crystals Packs Cold Formula
Manufacturer:Bayer Healthcare Llc, Consumer Care
Category:Over-the-counter (OTC) Marketed Drugs


Alka-SeltzerPlus®

ALKA-SELTZER PLUS FAST CRYSTALS PACKS COLD FORMULA - acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride granule, effervescent 
Bayer HealthCare LLC, Consumer Care

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alka-Seltzer
Plus®

Drug Facts

Active ingredients (in each powder packet)

Acetaminophen 650 mg

Chlorpheniramine maleate 4 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

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

Warnings

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

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 products containing acetaminophen
  • 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

  • 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 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.

Overdose Warning

Taking more than the recommended dose can cause serious health problems. 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 (see Overdose Warning)
  • adults and children 12 years and over:
    • dissolve contents of 1 powder packet in 6-8 ounces of hot or cold beverage: juice, soda, tea, coffee, (or water)
    • consume entire beverage within 15 minutes
  • take every 4 hours as needed
  • do not exceed 6 powder packets in 24 hours
  • children under 12 years: do not use

Other information

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

Inactive ingredients

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - packet

Alka-Seltzer
Plus®

FAST CRYSTAL PACK
COLD
formula
BAYER

Principle Display Panel - packet

PRINCIPAL DISPLAY PANEL - 10 packet carton

Alka-Seltzer
Plus®
NEW!

Acetaminophen/Pain reliever-fever reducer, Phenylephrine hydrochloride/Nasal decongestant
Chlorpheniramine maleate/Antihistamine

FAST CRYSTAL PACKS

FIZZ-FREE, TASTE-FREE
IN BEVERAGES
Alka-Seltzer
Plus

COLD
formula

BAYER

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

10
SINGLE DOSE
PACKETS

Principle Display Panel - 10 packet carton

PRINCIPAL DISPLAY PANEL - packet

Alka-Seltzer
Plus®

FAST CRYSTAL PACK
COLD
formula
BAYER

Principle Display Panel - packet

PRINCIPAL DISPLAY PANEL - 4 packet carton

Alka-Seltzer
Plus®
NEW!

Acetaminophen/Pain reliever-fever reducer,
Phenylephrine hydrochloride/Nasal decongestant,
Chlorpheniramine maleate/Antihistamine

FAST CRYSTAL PACKS

FIZZ-FREE, TASTE-FREE
IN BEVERAGES
Alka-Seltzer
Plus

COLD
formula

BAYER

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

4
SINGLE DOSE
PACKETS

Principle Display Panel - 4 packet carton

ALKA-SELTZER PLUS FAST CRYSTALS PACKS COLD FORMULA 
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride granule, effervescent
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-7180
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 650 mg
Chlorpheniramine maleate (Chlorpheniramine) Chlorpheniramine maleate 4 mg
Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride 10 mg
Product Characteristics
Color WHITE (White powder) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0280-7180-10 10 GRANULE, EFFERVESCENT ( PACKET) in 1 CARTON None
2 NDC:0280-7180-04 4 GRANULE, EFFERVESCENT ( PACKET) in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/10/2009

Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 08/2009 Bayer HealthCare LLC, Consumer Care



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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