Alka-Seltzer Plus Maximum Strength Night Cold and Flu (dextromethorphan hydrobromide 10 mg acetaminophen 325 mg doxylamine succinate 6.25 mg phenylephrine hydrochloride 5 mg) Dailymed
Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain 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
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Drug Facts
Otc - Active Ingredient Section
Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
Otc - Purpose Section
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
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 Section
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4000 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.
Do not use to sedate children.
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 ● 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
Otc - Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if you are
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers
Otc - When Using Section
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
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 D&C yellow #10, FD&C blue #1, 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)
Package Label.principal Display Panel
Alka-Selter PLUS ®
MAXIMUM STRENGTH Cold & Flu
NIGHT
ACETAMINOPHEN /Pain Reliever-Fever Reducer
Dextromethorphan Hydrobromide / Cough Suppresant
Doxylamine Succinate / Antihistamine
Phenylephrine HCl / Nasal Decongestant
- Cough
- Nasal Congestion
- Runny Nose
- Headache & Body Ache
- Sore Throat
20 LIQUID GELS (Liquid Filled Capsules)
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