Alka-Seltzer Plus Maximum Strength Day Cold and Flu (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed
Generic: acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular
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Drug Facts
Otc - Active Ingredient Section
Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
Otc - Purpose Section
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Indications & Usage Section
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache · cough
· sore throat · nasal and sinus congestion
· temporarily reduces fever
Warnings Section
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · bulers · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
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.
Otc - Do Not Use Section
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
Otc - Ask Doctor Section
Ask a doctor before use if you have
● liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes
● 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
Otc - Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - When Using Section
When using this product do not exceed recommended dosage
Otc - Stop Use Section
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
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
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. Quick medical attention
is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration Section
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
Other Information
Other information · store at room temperature. Avoid excessive heat above 40ºC
(104ºF).
Inactive Ingredient Section
Inactive ingredients FD&C yellow #6, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
Otc - Questions Section
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
Carton 20
Alka-Seltzer PLUS
MAXIMUM STRENGTH
Cold
& Flu
DAY NON-DROWSY
ACETAMINOPHEN / Pain Reliever-Fever Reducer
Dextromethorphan Hydrobromide / Cough Suppressant
Phenylephrine HCl / Nasal Decongestant
- Cough
- Nasal Congestion
- Headache & Body Ache
- Sore Throat
- Sinus Pressure
20 LIQUID GELS (Liquid Filled Capsules)
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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