Alka-Seltzer Plus ® Cold & Cough Formula
Drug Labeling and Warnings
Drug Details [pdf]
ALKA-SELTZER PLUS COLD AND COUGH FORMULA- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Bayer HealthCare LLC.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Alka-Seltzer Plus ® Cold & Cough Formula
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- nasal and sinus congestion
- cough
- runny nose
- sneezing
- sore throat
- 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
- 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
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
Inactive ingredients
FD&C blue #1, D&C red #33, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
PRINCIPAL DISPLAY PANEL - 10 Capsule Carton
OFFICIAL SPONSOR
Alka-
Seltzer
PLUS
®
Acetaminophen / Pain reliever-
fever reducer Chlorpheniramine
maleate / Antihistamine Dextromethorphan hydro-
bromide / Cough suppressant Phenylephrine
HCl / Nasal decongestant
COLD
& COUGH
FORMULA
Cough Nasal Congestion Runny Nose
Headache & Body Ache Sinus Pressure
10 LIQUID GELS (Liquid Filled Capsules)
| ALKA-SELTZER PLUS
COLD AND COUGH FORMULA
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled |
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| Labeler - Bayer HealthCare LLC. (112117283) |