Alka-Seltzer Plus Night Severe Cold and Flu
Dosage form: powder, for solution
Ingredients: ACETAMINOPHEN 650mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg, DOXYLAMINE SUCCINATE 12.5mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Bayer HealthCare LLC.
NDC Code: 0280-0922
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.
|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|
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- sore throat
- nasal congestion
- sinus congestion and pressure
- runny nose
- temporarily reduces fever
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
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.
- 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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- 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
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- 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
- 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.
- 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
- each packet contains: potassium 5 mg and sodium 5 mg
- store at room temperature
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
(Mon-Fri 9AM - 5PM EST)
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
Acetaminophen / Pain
Doxylamine succinate / Antihistamine
Phenylephrine HCl / Nasal decongestant
Dextromethorphan HBr / Cough
Fast Relief Mix-In Packets
COLD + FLU
• Nasal Congestion • Headache
• Sore Throat • Body Ache
• Cough • Runny Nose • Fever
|ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride powder, for solution
|Labeler - Bayer HealthCare LLC. (112117283)|
|Contract Pharmacal Corp.||968335112||manufacture(0280-0922), pack(0280-0922)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.