Drug Facts
1808ba46-e5ce-40d2-b62f-6a88de8aabf5
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 650 mg Diphenhydramine Hydochloride 25 mg Phenylephrine Hydrochloride 10 mg
Medication Information
Warnings and Precautions
LIVER WARNING : THIS PRODUCT CONTAINS ACETAMINOPHEN.SEVERE LIVER
DAMAGE MAY OCCUR IF ADULT TAKES MORE THAN 6 DOSES IN 24 HOURS
WHICH IS THE MAXIMUM DAILY AMOUNT, A CHILD TAKES MORE THAN 5 DOSES
IN 24 HOURS , WHICH IS THE MAXIMUM DAILY AMOUNT , TAKEN WITH OTHER
DRUGS CONTAINING ACETAMINOPHEN ,ADULT HAS 3 OR MORE ALCOHOLIC DRINKS
EVERYDAY WHILE USING THIS PRODUCT
Indications and Usage
Temporarily relieves symptoms associated with the common cold, flu, hay fever
and other respiratory allergies
nasal and sinus congestion
itching of the nose or throat
minor aches and pains
sneezing and runny nose
itchy, watery eyes
headaches
Dosage and Administration
Directions
adults and children 12 years of age and older: take 1 caplet every 4 hours as needed.
Do not exceed 6 doses In a 24 hour period or as directed by a doctor
children 6 to under 12 years of age: take 1/2 caplet every 4 hours as needed.
Do not exceed 5 doses In a 24 hour period or as directed by a doctor
children under 6 years of ago: consult a doctor
Description
Acetaminophen 650 mg Diphenhydramine Hydochloride 25 mg Phenylephrine Hydrochloride 10 mg
Section 34088-5
In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Section 42229-5
Other Information
_ store at 15'-30'C (59'-86'F)
Section 50565-1
Section 50566-9
- nervousness, dizziness or sleeplessness occur,
- pain symptoms do not improve after 7 days for adults or 5 days for children orlend to recur
_ cough and cold symptoms do not improve within 7 days or recur
_ symptoms are accompanied by fever that lasts more than 3 days
_ sore throat is severe or persists for more than 2 days
_ new symptoms occur or redness, swelling, rash, persistent headache, nausea or vomiting occur.
These could be signs of a serious condition
Section 50567-7
When using this product
marked drowsiness may occur _ excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase the drowsiness effect _ avoid alcoholic drinks _ use caution when driving a motor vehicle or operating machinery
Section 50568-5
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug "Warfarin"
Section 50569-3
Ask a doctor before use if the user has liver damage persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema, cough is accompanied by excessive phlegm (mucus), high blood pressure, thyroid disease, glaucoma, diabetes, heart disease, a breathing problem such as emphysema or chronic bronchitis, difficulty In urination due to enlargement of the prostate gland
Section 50570-1
Do not use _ with any other drug containing acetaminophen (prescription or nonpreescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist _ more than directed _ if you are taking sedatives or tranquilizers without first consulting your doctor _ if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's Disease) or for two weeks after stopping the MAD I drug if are uncertain whether your prescription drug contains an MAOI, consuit a health professional before taking this product
Section 51727-6
microcrystalline cellulose,polyvinylpyrrolidone,silica,sodium starch glycolate,starch,
stearic acid,titanium dioxide.
Section 51945-4
Section 53414-9
If pregnant or breast feeding, ask a health professional before use.
Section 55105-1
Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant
Section 55106-9
Acetaminophen 650 mg
Diphenhydramine Hydochloride 25 mg
Phenylephrine Hydrochloride 10 mg
Structured Label Content
Indications and Usage (34067-9)
Temporarily relieves symptoms associated with the common cold, flu, hay fever
and other respiratory allergies
nasal and sinus congestion
itching of the nose or throat
minor aches and pains
sneezing and runny nose
itchy, watery eyes
headaches
Dosage and Administration (34068-7)
Directions
adults and children 12 years of age and older: take 1 caplet every 4 hours as needed.
Do not exceed 6 doses In a 24 hour period or as directed by a doctor
children 6 to under 12 years of age: take 1/2 caplet every 4 hours as needed.
Do not exceed 5 doses In a 24 hour period or as directed by a doctor
children under 6 years of ago: consult a doctor
Warnings and Precautions (34071-1)
LIVER WARNING : THIS PRODUCT CONTAINS ACETAMINOPHEN.SEVERE LIVER
DAMAGE MAY OCCUR IF ADULT TAKES MORE THAN 6 DOSES IN 24 HOURS
WHICH IS THE MAXIMUM DAILY AMOUNT, A CHILD TAKES MORE THAN 5 DOSES
IN 24 HOURS , WHICH IS THE MAXIMUM DAILY AMOUNT , TAKEN WITH OTHER
DRUGS CONTAINING ACETAMINOPHEN ,ADULT HAS 3 OR MORE ALCOHOLIC DRINKS
EVERYDAY WHILE USING THIS PRODUCT
Section 34088-5 (34088-5)
In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Section 42229-5 (42229-5)
Other Information
_ store at 15'-30'C (59'-86'F)
Section 50565-1 (50565-1)
Section 50566-9 (50566-9)
- nervousness, dizziness or sleeplessness occur,
- pain symptoms do not improve after 7 days for adults or 5 days for children orlend to recur
_ cough and cold symptoms do not improve within 7 days or recur
_ symptoms are accompanied by fever that lasts more than 3 days
_ sore throat is severe or persists for more than 2 days
_ new symptoms occur or redness, swelling, rash, persistent headache, nausea or vomiting occur.
These could be signs of a serious condition
Section 50567-7 (50567-7)
When using this product
marked drowsiness may occur _ excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase the drowsiness effect _ avoid alcoholic drinks _ use caution when driving a motor vehicle or operating machinery
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug "Warfarin"
Section 50569-3 (50569-3)
Ask a doctor before use if the user has liver damage persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema, cough is accompanied by excessive phlegm (mucus), high blood pressure, thyroid disease, glaucoma, diabetes, heart disease, a breathing problem such as emphysema or chronic bronchitis, difficulty In urination due to enlargement of the prostate gland
Section 50570-1 (50570-1)
Do not use _ with any other drug containing acetaminophen (prescription or nonpreescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist _ more than directed _ if you are taking sedatives or tranquilizers without first consulting your doctor _ if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's Disease) or for two weeks after stopping the MAD I drug if are uncertain whether your prescription drug contains an MAOI, consuit a health professional before taking this product
Section 51727-6 (51727-6)
microcrystalline cellulose,polyvinylpyrrolidone,silica,sodium starch glycolate,starch,
stearic acid,titanium dioxide.
Section 51945-4 (51945-4)
Section 53414-9 (53414-9)
If pregnant or breast feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant
Section 55106-9 (55106-9)
Acetaminophen 650 mg
Diphenhydramine Hydochloride 25 mg
Phenylephrine Hydrochloride 10 mg
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Source: dailymed · Ingested: 2026-02-15T11:55:07.206969 · Updated: 2026-03-14T22:52:27.184723