Indications and uses
for the temporary relief of these symptoms associated with menstrual periods: • bloating • headache • muscle aches • cramps • backache • fatigue • water-weight gain
for the temporary relief of these symptoms associated with menstrual periods: • bloating • headache • muscle aches • cramps • backache • fatigue • water-weight gain
• do not take more than the recommended dose • adults and children 12 years and over: • take 2 caplets with water • repeat every 6 hours, as needed • do not exceed 6 caplets per day • children under 12 years: ask a doctor
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • see end flap for expiration date and lot number • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg
Pain reliever
Diuretic
Antihistamine
for the temporary relief of these symptoms associated with menstrual periods:
• bloating • headache • muscle aches
• cramps • backache • fatigue
• water-weight gain
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours
• 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.
Do not use • if you have ever had an allergic reaction to this product or any of its ingredients
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
• difficulty in urination due to enlargement of the prostate gland • liver disease • glaucoma
• 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
• excitability may occur, especially in children
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness • you may get drowsy
• limit the use of caffeine-containing medications, foods, or beverages while taking this product because 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.
• avoid alcoholic beverages
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
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. 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.
• do not take more than the recommended dose
• adults and children 12 years and over:
• take 2 caplets with water
• repeat every 6 hours, as needed
• do not exceed 6 caplets per day
• children under 12 years: ask a doctor
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• see end flap for expiration date and lot number
• Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin
1-800-426-9391
Maximum Strength
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
OPOSITIV.COM
Distributed By: O Positiv, Inc.
11740 San Vicente Blvd Los Angeles, CA 90049
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1597298 | acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet | PSN | 4 |
| 1597298 | acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet | SCD | 4 |
| 1597298 | APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral Tablet | SY | 4 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83049-489-08 | FLO PMS Complete | 8 in 1 BLISTER PACK | TABLET | 8 | 4 | |
| 83049-489-08 | FLO PMS Complete | 3 in 1 CARTON | TABLET | 3 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83049-489 | 83049-489-08 |
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 |
|---|---|---|---|---|---|---|
| FLO PMS Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | O Positiv, Inc. | cce62d9f-adb1-4473-8258-910dff6b1378 | 2023-10-09 | Warnings | 83049-489-08 83049-489 83049048908 a0526808-00a6-42a5-aeb8-42db54626a28 cce62d9f-adb1-4473-8258-910dff6b1378 |
Adverse event summaries are temporarily unavailable. Other product information remains available.