Alka-Seltzer Plus description, usages, side effects, indications, overdosage, supplying and lots more!

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Alka-Seltzer Plus

Bayer HealthCare LLC, Consumer Care

Alka-Seltzer Plus Night Cold & Flu Formula 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
Dextromethorphan hydrobromide 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine hydrochloride 5 mg Nasal decongestant

Alka-Seltzer Plus Uses

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

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

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 10 capsules in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Alka-Seltzer Plus Other information

  • store at room temperature. Avoid excessive heat.

Inactive ingredients

FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 20 Capsule Carton

OFFICIAL SPONSOR

Alka-
Seltzer
PLUS®

Acetaminophen / Pain reliever-fever
reducer • Dextromethorphan
hydrobromide / Cough suppressant • Doxylamine
succinate / Antihistamine • Phenylephrine HCl
Nasal decongestant

NIGHT
COLD & FLU FORMULA

Nasal Congestion • Cough • Runny Nose
Headache & Body Ache • Sore Throat

20 LIQUID GELS (Liquid Filled Capsules)

Alka-Seltzer Plus

Alka-Seltzer Plus

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0280-1124
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
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
D&C YELLOW NO. 10
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
water
SHELLAC
SODIUM HYDROXIDE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GREEN 20 mm AS;Nite OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:0280-1124-20 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-10-30


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Be sure to consult your doctor before taking any medication!
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