Alka-Seltzer Plus-D Multi-Symptom Sinus and Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Alka-Seltzer Plus-D Multi-Symptom Sinus and Cold

Bayer HealthCare LLC, Consumer Care

Alka-Seltzer Plus-D Multi-Symptom Sinus & Cold Liquid Gels


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each capsule) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg Antihistamine
Dextromethorphan hydrobromide 10 mg Cough suppressant
Pseudoephedrine HCl 30 mg Nasal decongestant

Alka-Seltzer Plus-D Multi-Symptom Sinus and Cold 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

Alka-Seltzer Plus-D Multi-Symptom Sinus and Cold 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)

Alka-Seltzer Plus-D Multi-Symptom Sinus and Cold

Alka-Seltzer Plus-D Multi-Symptom Sinus and Cold

Acetaminophen, Dextromethorphan hydrobromide, chlorpheniramine maleate, and pseudoephedrine Hydrochloride CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0280-1197
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
PURPLE 20 mm AS;D OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BLISTER PACK
2 NDC:0280-1197-20 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-08-01


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Be sure to consult your doctor before taking any medication!
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