Overview
- Active ingredient
- Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
- Route
- Oral
- Label date
- 2026-09-02
Indications and usage
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
Dosage and administration
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
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.
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
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
Ask a doctor or pharmacist before use if
- you are taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
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
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.
Overdosage
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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Active ingredient (label)
s (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
Inactive ingredients
s anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate ,propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Storage and handling
Other information
- each 20 mL contains: sodium 6 mg
- low sodium
- store at room temperature
- do not refrigerate
- dosing cup provided
Keep out of reach of children
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.