Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Maximum Strength Nighttime Cold and Flu — THE KROGER CO
This page contains 17 source sections for ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL, oral route. Label set 058b2021-8a61-40b0-8a2e-a784d2b847fb, version 8.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses • temporarily relieves these common cold and flu symptoms: • cough • nasal congestion • minor aches and pains • sore throat • headache • runny nose • sneezing • temporarily reduces fever • controls cough to help you get to sleep
Purpose
Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine/cough suppressant Phenylephrine HCl 10 mg Nasal decongestant
Table text from source:
| Active ingredients (in each 20 mL) | Purposes
|
| Acetaminophen 650 mg | Pain reliever/fever reducer
| Diphenhydramine HCl 25 mg | Antihistamine/cough suppressant
| Phenylephrine HCl 10 mg | Nasal decongestant
Dosage and administration — label text
Directions • do not take more than directed (see Overdose warning) • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • mL= milliliter • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours • children under 12 years of age: do not use
Warnings
Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin reactions .Symptoms may include: • Skin reddening • Blisters • rash If a skin 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 • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • with any other drug containing diphenhydramine, even one used on the skin • 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. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) 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 use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion, or cough 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 fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Unclassified section
Drug Facts
Active ingredient
Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine/cough suppressant Phenylephrine HCl 10 mg Nasal decongestant
Table text from source:
| Active ingredients (in each 20 mL) | Purposes
|
| Acetaminophen 650 mg | Pain reliever/fever reducer
| Diphenhydramine HCl 25 mg | Antihistamine/cough suppressant
| Phenylephrine HCl 10 mg | Nasal decongestant
Do not use
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. • with any other drug containing diphenhydramine, even one used on the skin • 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.
Ask a doctor before use
Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if • you are taking the blood thinning drug warfarin • taking sedatives or tranquilizers
While using this medicine
When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery
When to stop use and seek help
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion, or cough 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Overdose information
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Storage and handling
Other information • each 20 mL contains: sodium 6 mg • low sodium • store at room temperature • do not refrigerate • dosing cup provided
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.