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Alka-Seltzer Plus Severe Allergy Sinus Congestion And Headache Formula

Dosage form: capsule, liquid filled
Ingredients: Acetaminophen 325mg, Doxylamine succinate 6.25mg, Phenylephrine hydrochloride 5mg
Labeler: Bayer HealthCare LLC, Consumer Care
NDC Code: 0280-1198

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.

Alka-Seltzer Plus® Severe Allergy Sinus Congestion & Headache Formula

Drug Facts

Active ingredients (in each capsule)Purpose
Acetaminophen 325 mgPain reliever
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine hydrochloride 5 mgNasal decongestant

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
    • runny nose
    • sneezing
    • itchy, water eyes
    • itching of the nose or throat
    • nasal congestion
    • sinus congestion and pressure
    • headache
    • minor aches and pains
  • temporarily restores freer breathing through the nose

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

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

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 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
  • 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 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

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

PRINCIPAL DISPLAY PANEL - 20 Capsule Carton

NEW!
Liquid Gels

Alka-
Seltzer
PLUS
®
Doxylamine succinate /
Antihistamine
Phenylephrine HCl / Nasal decongestant
Acetaminophen / Pain reliever

SEVERE
ALLERGY
SINUS CONGESTION & HEADACHE
Liquid Gels

Nasal & Sinus Congestion • Sinus Pressure
Runny Nose & Sneezing • Headache & Pain

20 LIQUID GELS (Liquid Filled Capsules)

ALKA-SELTZER PLUS SEVERE ALLERGY SINUS CONGESTION AND HEADACHE FORMULA 
acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1198
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Doxylamine succinate (Doxylamine) Doxylamine succinate6.25 mg
Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C blue No. 1 
gelatin 
glycerin 
mannitol 
polyethylene glycol 400 
povidone k30 
propylene glycol 
water 
shellac 
sorbitan 
sorbitol 
titanium dioxide 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize20mm
FlavorImprint CodeAS;SH
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-1198-2010 BLISTER PACK in 1 CARTON
12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34308/01/2012
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 06/2012
 
Bayer HealthCare LLC, Consumer Care

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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