OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 500mg; Caffeine 65mg
Acetaminophen 500mg; Caffeine 65mg
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
| 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 |
*temporarily relieves minor aches and pains due to:
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
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
Ask a doctor before use if you have
Ask a doctor or a pharmacist before use if
you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
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.
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.
Pain reliever ; Pain reliever aid
| Class | Version | Type | Effective |
|---|---|---|---|
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7dea7767-9f52-b60a-5435-33cb9cc28bae | Product name | 4 | 20250124 |
| 6338270f-96cb-0ecb-6fbb-0a9bc78001f4 | Product name | 7 | 20250116 |
| 0ca83774-3f79-b837-5d6f-c210102f3bc8 | Product name | 6 | 20250114 |
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 2dc76302-91c0-4c35-ad78-99adfb049c4b | Product name | 1 | 20200603 |
| e6065d4b-5ae1-476f-a40e-f2851cbb5d2b | Product name | 2 | 20180221 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 332e86c3-7875-ca6e-f934-2206d2b31996 | Product name | 1 | 20140508 |
| 56625fcc-aa34-9d30-d0e9-1c1beb37ea21 | Product name | 1 | 20140508 |
| 7dfac40f-a405-cd2e-7c06-3059ec0e1092 | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| d223c173-c39b-d764-47d4-d671d3088815 | Product name | 1 | 20140508 |
| e01133ad-4dcd-c7f3-454b-2ff569ee160a | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70692-110-41 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b351-a426-e053-dadaa90af4c2 | Headache - Dolor de Cabeza (Acetaminophen 500mg; Caffeine 65mg) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70692-110-41 | Acetaminophen 500mg Caffeine 65mg | 4 in 1 PACKAGE | TABLET | 4 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70692-110 | 70692-110-41 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b43d36ae-9a0a-8e9a-e053-2995a90af293 | 92355f58-ebb6-b78f-e053-2995a90a4aef | 2020-11-16 | Warnings | b43d36ae-9a0a-8e9a-e053-2995a90af293 92355f58-ebb6-b78f-e053-2995a90a4aef |
Adverse event summaries are temporarily unavailable. Other product information remains available.