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Name:Alka-seltzer Plus Day Non Drowsy Cold Medicine Citrus
Manufacturer:Bayer Healthcare Llc, Consumer Care
Category:Over-the-counter (OTC) Marketed Drugs


Alka-Seltzer Plus® Day Non-Drowsy Cold Formula Effervescent Tablets

ALKA-SELTZER PLUS  DAY NON DROWSY COLD MEDICINE CITRUS - aspirin, dextromethorphan hydrobromide and phenylephrine bitartrate tablet, 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® Day Non-Drowsy Cold Formula
Effervescent Tablets

Drug Facts

Active ingredients (in each tablet) Purposes
Aspirin 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine bitartrate 7.8 mg Nasal decongestant

Uses

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

Warnings

Reye's syndrome

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

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

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • 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

  • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
  • bleeding problems
  • heart disease
  • diabetes
  • ulcers
  • high blood pressure
  • glaucoma
  • asthma
  • thyroid disease
  • cough with excessive phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • anticoagulation (blood thinning)
  • diabetes
  • gout
  • arthritis

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • ringing in the ears or loss of hearing occurs
  • 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.

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information

  • each tablet contains: sodium 416 mg
  • Phenylketonurics: Contains Phenylalanine 9 mg per tablet
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - Shipper Label

ALKA-SELTZER PLUS®
DAY NON-DROWSY COLD

3200 TABLETS 1600 PIECES

SHIPPER
CODE
1 00 16500 54212 1

MADE IN
MEXICO

PRODUCT CODE

82411357

STORE AT ROOM
TEMPERATURE.
AVOID EXCESSIVE HEAT

Bayer HealthCare LLC
Consumer Care
P.O. Box 1910, Morristown, NJ
07962-1910 USA

Principal Display Panel – Shipper Label

ALKA-SELTZER PLUS   DAY NON DROWSY COLD MEDICINE CITRUS
aspirin, dextromethorphan hydrobromide, and phenylephrine bitartrate tablet, effervescent
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1410
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aspirin (Aspirin) Aspirin 325 mg
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide 10 mg
Phenylephrine bitartrate (Phenylephrine) Phenylephrine bitartrate 7.8 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 26mm
Flavor CITRUS Imprint Code ASP;ND
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0280-1410-32 1600 POUCH ( POUCH) in 1 CASE contains a POUCH
1 2 TABLET, EFFERVESCENT ( TABLET) in 1 POUCH This package is contained within the CASE (0280-1410-32)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 08/01/2010

Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 07/2010 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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