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Alka-Seltzer Plus Cold Night (aspirin 500 mg dextromethorphan hydrobromide 10 mg doxylamine succinate 6.25 mg phenylephrine bitartrate 7.8 mg) Dailymed

  1. Human OTC
  2. Platelet Aggregation Inhibitor
  3. Bayer HealthCare LLC.

Generic: aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate is used for the treatment of Cough Arthritis, Rheumatoid Blood Coagulation Disorders Blood Platelet Disorders Cerebral Infarction Ischemic Attack, Transient Chickenpox Child, Preschool Fever Gout Hematemesis Hemorrhagic Disorders Infant Inflammation Melena Myocardial Infarction Nasal Polyps Osteoarthritis Pain Pre-Eclampsia Pregnancy Trimester, Third Rheumatic Fever Headache Sleep Initiation and Maintenance Disorders Rhinitis, Allergic, Perennial Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular

Alka-Seltzer Plus Cold Night tablet, effervescent - (aspirin 500 mg dextromethorphan hydrobromide 10 mg doxylamine succinate 6.25 mg phenylephrine bitartrate 7.8 mg) image

IMPRINT: ASP NT     SHAPE: round
    COLOR: white

  1. FDA Adverse Reactions

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Drug Facts

Otc - Active Ingredient Section


Active ingredients (in each tablet)

Aspirin 500 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Otc - Purpose Section


Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses


Uses

â— temporarily relieves these symptoms due to a cold:

â— minor aches and pains â— headache â— runny nose

â— sinus congestion and pressure â— cough â— sneezing

â— sore throat â— nasal congestion

â— temporarily reduces fever

Warnings Section


Warnings

Reye’s syndrome: Children and teenagers who have or are

recovering from chicken pox or flu-like symptoms should not use this

product. When using this product, if changes in behavior with nausea

and vomiting occur, consult a doctor because these symptoms could be

an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may

include:

â— hives â— facial swelling â— asthma (wheezing) â— shock

Stomach bleeding warning: This product contains an NSAID, which

may cause severe stomach bleeding. The chance is higher if you

â— are age 60 or older

â— have had stomach ulcers or bleeding problems

â— take a blood thinning (anticoagulant) or steroid drug

â— take other drugs containing prescription or nonprescription NSAIDs

(aspirin, ibuprofen, naproxen, or others)

â— have 3 or more alcoholic drinks every day while using this product

â— take more or for a longer time than directed

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.

Otc - Do Not Use Section


Do not use

â— if you are allergic to aspirin or any other pain reliever/fever reducer

â— 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.

â— if you have ever had an allergic reaction to this product or any of its

ingredients

â— in children under 12 years of age

Otc - Ask Doctor Section


Ask a doctor before use if

â— stomach bleeding warning applies to you

â— you have a history of stomach problems, such as heartburn

â— you have high blood pressure, heart disease, liver cirrhosis, or

kidney disease

â— you are taking a diuretic

â— you have

â— asthma â— diabetes â— thyroid disease â— glaucoma

â— cough with excessive phlegm (mucus)

â— a breathing problem such as emphysema or chronic bronchitis

â— difficulty in urination due to enlargement of the prostate gland

â— persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

â— a sodium-restricted diet

Otc - Ask Doctor/pharmacist Section


Ask a doctor or pharmacist before use if you are

â— taking a prescription drug for

â— gout â— diabetes â— arthritis

â— taking sedatives or tranquilizers

Otc - When Using Section


When using this product

â— do not exceed recommended dosage

â— may cause marked drowsiness

â— avoid alcoholic drinks

â— alcohol, sedatives, and tranquilizers may increase drowsiness

â— be careful when driving a motor vehicle or operating machinery

â— excitability may occur, especially in children

Otc - Stop Use Section


Stop use and ask a doctor if

â— an allergic reaction occurs. Seek medical help right away.

â— you experience any of the following signs of stomach bleeding

â— feel faint â— vomit blood â— have bloody or black stools

â— have stomach pain that does not get better

â— pain, cough, or nasal congestion gets worse or lasts more than 7 days

â— fever gets worse or lasts more than 3 days

â— redness or swelling is present

â— new symptoms occur

â— ringing in the ears or a loss of hearing occurs

â— cough comes back or occurs with rash or headache that lasts. These

could be signs of a serious condition.

â— nervousness, dizziness, or sleeplessness occurs

Otc - Pregnancy Or Breast Feeding Section


If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use aspirin during the last 3

months of pregnancy unless definitely directed to do so by a

doctor because it may cause problems in the unborn child or

complications during delivery.

Otc - Keep Out Of Reach Of Children Section


Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away

Directions


Directions

â— adults and children 12 years and over: take 2 tablets fully dissolved

in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not

exceed 8 tablets in 24 hours or as directed by a doctor.

â— children under 12 years: do not use

Other Information


Other information

â— each tablet contains: sodium 476 mg

â— Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

â— store at room temperature. Avoid excessive heat.

Inactive Ingredient Section


Inactive ingredients acesulfame potassium, anhydrous citric

acid, aspartame, calcium silicate, dimethicone, docusate sodium,

flavors (natural & artificial), mannitol, povidone, sodium benzoate,

sodium bicarbonate

Questions Or Comments?


Questions or comments? 1-800-986-0369 (Mon-Fri 9AM -

5PM EST)

Package Label.principal Display Panel


Alka-Seltzer

Plus ®

Cold

Night

Lemon

ASPIRIN ( NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine Bitartrate / Nasal Decongestant
  • Nasal Congestion
  • Headache & Body Ache
  • Cough
  • Runny Nose
  • Sore Throat

20 EFFERVESCENT TABLETS



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