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.
Active Ingredient
Acetaminophen 500mg; Caffeine 65mg
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 60561-8
- store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
Structured Label Content
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.
Active Ingredient (55106-9)
Acetaminophen 500mg; Caffeine 65mg
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 |
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 60561-8 (60561-8)
- store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:59:03.228262 · Updated: 2026-03-14T22:58:52.562418