Drug Facts
f94ed467-b986-4ee2-b0df-f5f6d7e87a15
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each tablet) Acetaminophen 162.5 mg Chlorpheniramine maleate 1 mg
Medication Information
Warnings and Precautions
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
adult takes more than 24 tablets in 24 hours, which is the maximum daily amount for this product
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday while using this product
Do not give to children under 6 years of age unless directed by a doctor.
Indications and Usage
temporarily relieves these symptoms due to a cold, the flu, or hay fever:
minor aches and pains headache
sore throat
sneezing
runny nose
itchy, watery eyes
itching of the nose or throat
temporarily reduces fever
Dosage and Administration
adults and children 12 years of age and older: 4 tablets every 4 to 6 hours, not to exceed 6 doses (24 tablets) in 24 hours, or as directed by a doctor
children 6 to under 12 years of age: 2 tablets every 4 to 6 hours, not to exceed 5 doses (10 tablets) in 24 hours, or as directed by a doctor
children under 6 years: consult a doctor of age
Description
Active ingredient (in each tablet) Acetaminophen 162.5 mg Chlorpheniramine maleate 1 mg
Section 44425-7
Other information
keep tightly sealed
store between 15º to 30º C (59º to 86º F)
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control
Center right away. Prompt medical attention is critical for adults as well as for children even if you do
not notice any signs or symptoms.
Section 50566-9
Stop use and ask a doctor if
sore throat is severe
sore throat persists for more than 2 days
sore throat is accompanied or followed by:
fever
headache
rash
nausea
vomiting
any of the following occurs (these could be signs of a serious condition):
pain or fever persists or gets worse or new symptoms occur
redness or swelling is present
Section 50567-7
When using this product
do not exceed recommended dosage
avoid alcoholic beverages
may cause drowsiness (alcohol, sedatives, and tranquilizers may increase the drowsiness effect)
use caution when driving or operating machinery
may cause excitability especially in children
Section 50568-5
Ask a doctor or pharmacist before use if the user is
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
Section 50569-3
Ask a doctor before use if the user has
liver disease
glaucoma
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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
for pain for more than 10 days (for adults) or 5 days (for children)
for fever for more than 3 days
Section 51727-6
Scutellaria baicalensis root, platycodon grandiflorum leaf, arctium lappa fruit, mint, FDC blue no. 2, FDC yellow no.5, FDC yellow no.6, titanium dioxide, soybean, forsythia suspensa fruit, lonicera japonica flower, hypromellose 2910 (15000 mpa.s), glycyrrhiza uralensis, notopterygium incisum root, phragmites australis root, polydextrose, polyethylene glycol 4000, schizonepeta tenufolia spike
Section 51945-4
Section 53413-1
Questions or Comments? (888) 221-3496 M-F 9 am to 5 pm
you may also use this number to report serious adverse events associated with the use of this product
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Pain reliever-fever reducer
Antihistamine
Section 55106-9
Active ingredient (in each tablet)
Acetaminophen 162.5 mg
Chlorpheniramine maleate 1 mg
Structured Label Content
Indications and Usage (34067-9)
temporarily relieves these symptoms due to a cold, the flu, or hay fever:
minor aches and pains headache
sore throat
sneezing
runny nose
itchy, watery eyes
itching of the nose or throat
temporarily reduces fever
Dosage and Administration (34068-7)
adults and children 12 years of age and older: 4 tablets every 4 to 6 hours, not to exceed 6 doses (24 tablets) in 24 hours, or as directed by a doctor
children 6 to under 12 years of age: 2 tablets every 4 to 6 hours, not to exceed 5 doses (10 tablets) in 24 hours, or as directed by a doctor
children under 6 years: consult a doctor of age
Warnings and Precautions (34071-1)
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
adult takes more than 24 tablets in 24 hours, which is the maximum daily amount for this product
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday while using this product
Do not give to children under 6 years of age unless directed by a doctor.
Section 44425-7 (44425-7)
Other information
keep tightly sealed
store between 15º to 30º C (59º to 86º F)
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control
Center right away. Prompt medical attention is critical for adults as well as for children even if you do
not notice any signs or symptoms.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
sore throat is severe
sore throat persists for more than 2 days
sore throat is accompanied or followed by:
fever
headache
rash
nausea
vomiting
any of the following occurs (these could be signs of a serious condition):
pain or fever persists or gets worse or new symptoms occur
redness or swelling is present
Section 50567-7 (50567-7)
When using this product
do not exceed recommended dosage
avoid alcoholic beverages
may cause drowsiness (alcohol, sedatives, and tranquilizers may increase the drowsiness effect)
use caution when driving or operating machinery
may cause excitability especially in children
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if the user is
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
Section 50569-3 (50569-3)
Ask a doctor before use if the user has
liver disease
glaucoma
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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
for pain for more than 10 days (for adults) or 5 days (for children)
for fever for more than 3 days
Section 51727-6 (51727-6)
Scutellaria baicalensis root, platycodon grandiflorum leaf, arctium lappa fruit, mint, FDC blue no. 2, FDC yellow no.5, FDC yellow no.6, titanium dioxide, soybean, forsythia suspensa fruit, lonicera japonica flower, hypromellose 2910 (15000 mpa.s), glycyrrhiza uralensis, notopterygium incisum root, phragmites australis root, polydextrose, polyethylene glycol 4000, schizonepeta tenufolia spike
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or Comments? (888) 221-3496 M-F 9 am to 5 pm
you may also use this number to report serious adverse events associated with the use of this product
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Pain reliever-fever reducer
Antihistamine
Section 55106-9 (55106-9)
Active ingredient (in each tablet)
Acetaminophen 162.5 mg
Chlorpheniramine maleate 1 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:12.824359 · Updated: 2026-03-14T22:52:35.540850