Your browser does not support JavaScript! ALKA-SELTZER PLUS-D MULTI-SYMPTOM SINUS AND COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]
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ALKA-SELTZER PLUS-D MULTI-SYMPTOM SINUS AND COLD (acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate, and pseudoephedrine hydrochloride) capsule, liquid filled
[Bayer HealthCare LLC, Consumer Care]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredients (in each capsule)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan hydrobromide 10 mgCough suppressant
Pseudoephedrine HCl 30 mgNasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion and pressure
    • cough
    • sore throat
    • sneezing
    • runny nose
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
  • temporarily reduces fever

Warnings

Liver warning

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

  • more than 8 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

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

Other information

  • each capsule contains: potassium 25 mg
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

D&C red #33, FD&C blue #1, fractionated coconut, gelatin, glycerin, lecithin, polyethylene glycol, polyvinyl acetate phthalate, potassium acetate, povidone, propylene glycol, purified water, sorbitol sorbitan solution, 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 Blister Pack Carton

NEW!

Alka-
Seltzer
PLUS®-D

Acetaminophen / Pain reliever-fever
reducer • Chlorpheniramine
maleate / Antihistamine
• Dextromethorphan hydrobromide / Cough
suppressant • Pseudoephedrine HCl /
Nasal decongestant

MULTI-SYMPTOM

SINUS & COLD
FORMULA

BAYER

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

20 LIQUID GELS (Liquid Filled Capsules)

PRINCIPAL DISPLAY PANEL - 20 Capsule Blister Pack Carton
ALKA-SELTZER PLUS-D MULTI-SYMPTOM SINUS AND COLD 
acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate, and pseudoephedrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0280-1197
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide10 mg
chlorpheniramine maleate (chlorpheniramine) chlorpheniramine maleate2 mg
pseudoephedrine Hydrochloride (pseudoephedrine) pseudoephedrine Hydrochloride30 mg
Inactive Ingredients
Ingredient NameStrength
D&C red NO. 33 
FD&C blue NO. 1 
medium-chain triglycerides 
gelatin 
glycerin 
Lecithin, Soybean 
polyethylene glycol 400 
polyvinyl acetate phthalate 
potassium acetate 
povidone K30 
propylene glycol 
water 
sorbitan 
sorbitol 
titanium dioxide 
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize20mm
FlavorImprint Code AS;D
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-1197-201 in 1 CARTON
120 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2013
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 5/2013
 
Bayer HealthCare LLC, Consumer Care

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