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

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Alka-Seltzer Plus Night Severe Cold and Flu

Bayer HealthCare Consumer Care

Alka-Seltzer Plus Night Severe Cold + Flu


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Doxylamine succinate 12.5 mg Antihistamine
Phenylephrine hydrochloride 10 mg Nasal decongestant

Alka-Seltzer Plus Night Severe Cold and Flu Uses

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

Warnings

Liver warning

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

  • more than 5 packets 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
  • take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
  • adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • children under 12 years: do not use

Alka-Seltzer Plus Night Severe Cold and Flu Other information

  • each packet contains: potassium 5 mg and sodium 5 mg
  • store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, pregelatinized starch, sodium citrate, sucralose, tartaric acid, tribasic calcium phosphate

Questions or comments?

1-800-986-0369
(Mon-Fri 9AM - 5PM EST)

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

NEW!

OFFICIAL SPONSOR

Alka-
Seltzer
PLUS
®

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

Honey Lemon
Fast Relief Mix-In Packets

NIGHT
SEVERE
COLD + FLU

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

6 PACKETS

Alka-Seltzer Plus Night Severe Cold and Flu

Alka-Seltzer Plus Night Severe Cold and Flu

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0280-0922
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 12.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
SODIUM CITRATE
Sucralose
tartaric acid
TRIBASIC CALCIUM PHOSPHATE

Product Characteristics

Color
YELLOW

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 PACKET
2 NDC:0280-0922-06 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-04-17


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Be sure to consult your doctor before taking any medication!
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