Headache - Dolor De Cabeza (acetaminophen 500mg; Caffeine 65mg)
92355f58-ebb6-b78f-e053-2995a90a4aef
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500mg; Caffeine 65mg
Medication Information
Warnings and Precautions
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 caplets in 24 hours, which is the maimum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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
Caffeine warning:
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while takingthis product because too much caffeine may cause nervousness, irritability, sleeplessness, and occassionally rapis heart beat.
Do not use
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask a doctor before use if you have
- liver disease
Ask a doctor or a pharmacist before use if
you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- new symptoms occur
- painful area is red or swollen
These could be signs of a serious comdition
If pregnant or breast-feeding,
ask a health professional before use
Keep out of reach of children
Overdose warning: In case of accidental 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.
Indications and Usage
*temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Dosage and Administration
- take with a full glass of water
- do not take more than directed
- do not take more than 6 caplets in 24 hours
| adults and children 12 years of age and over | take 2 caplets every 6 hours, not more than 6 caplets in 24 hours |
| children under 12 years of age | ask a doctor |
Description
Acetaminophen 500mg; Caffeine 65mg
Section 50565-1
Keep out of reach of children
Overdose Warning: In case of accidental 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 51727-6
colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #2, FD&C yellow #6, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, pregalatinized starch, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide
Section 51945-4
Section 55105-1
Pain reliever ; Pain reliever aid
Section 55106-9
Acetaminophen 500mg; Caffeine 65mg
Section 60561-8
- store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
Structured Label Content
Indications and Usage (34067-9)
*temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Dosage and Administration (34068-7)
- take with a full glass of water
- do not take more than directed
- do not take more than 6 caplets in 24 hours
| adults and children 12 years of age and over | take 2 caplets every 6 hours, not more than 6 caplets in 24 hours |
| children under 12 years of age | ask a doctor |
Warnings and Precautions (34071-1)
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 caplets in 24 hours, which is the maimum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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
Caffeine warning:
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while takingthis product because too much caffeine may cause nervousness, irritability, sleeplessness, and occassionally rapis heart beat.
Do not use
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask a doctor before use if you have
- liver disease
Ask a doctor or a pharmacist before use if
you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- new symptoms occur
- painful area is red or swollen
These could be signs of a serious comdition
If pregnant or breast-feeding,
ask a health professional before use
Keep out of reach of children
Overdose warning: In case of accidental 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 50565-1 (50565-1)
Keep out of reach of children
Overdose Warning: In case of accidental 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 51727-6 (51727-6)
colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #2, FD&C yellow #6, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, pregalatinized starch, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Pain reliever ; Pain reliever aid
Section 55106-9 (55106-9)
Acetaminophen 500mg; Caffeine 65mg
Section 60561-8 (60561-8)
- store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
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Source: dailymed · Ingested: 2026-02-15T11:59:03.228262 · Updated: 2026-03-14T22:58:52.562418