Active ingredient (in each gelcap)
Acetaminophen USP 500mg
Caffeine USP 60mg
Pyrilamine maleate USP 15mg
Acetaminophen USP 500mg
Caffeine USP 60mg
Pyrilamine maleate USP 15mg
purpose
Uses
for the temporary relief of these symptoms associated with menstural periods:
• cramps
• bloating
• waterweight gain
• headache
• backache
• muscle aches
• fatigue
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 6 gelcap in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions.
Symptoms may include: • hives • blisters • rash • skin reddening • facial swelling • asthma (wheezing) • shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
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
• if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
• liver disease
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
When using this product
• you may get drowsy
• avoid alcoholic drinks
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• limit the use of caffeine-containing medications, foods, or beverages beacuse too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop use and ask a doctor if
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children.
Overdose warning: 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 children even if you do not notice any signs or symptoms.
Directions
• do not take more than the recommended dose
• adults and children 12 years and older: take 2 gelcap with water
• repeat every 6 hours as needed
• do not exceed 6 gelcap per day
• children under 12 years: consult a doctor
store at room temperature.
Inactive ingredients
croscarmellose sodium, D&C red 33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue 1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, purified water, PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 701913 | acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Capsule | PSN | 1 |
| 701913 | acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Capsule | SCD | 1 |
| 701913 | APAP 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Capsule | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-1234-1 | Acetaminophen , Caffeine and pyrilamine maleate | 1500 in 1 BAG | CAPSULE | 1500 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35916-1234 | 35916-1234-1 |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen , Caffeine and pyrilamine maleate | ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE | Softgel Healthcare Pvt Ltd | 4a61313e-1b48-29df-e063-6394a90a27f0 | 2026-02-09 | Warnings | 35916-1234-1 35916-1234 35916123401 4a61316b-db1b-cae8-e063-6294a90adce2 4a61313e-1b48-29df-e063-6394a90a27f0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.