FLO PMS Complete

Manufacturer
O Positiv, Inc.
Effective date
2023-10-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:56:33

Label at a glance#

ProductFLO PMS Complete
Active ingredientACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Label structure10 sections

Indications and uses

for the temporary relief of these symptoms associated with menstrual periods: • bloating   • headache  • muscle aches • cramps    • backache   • fatigue • water-weight gain

Dosage and administration

• 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

Storage and handling

• 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)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever
Diuretic
Antihistamine

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of these symptoms associated with menstrual periods:
• bloating   • headache  • muscle aches
• cramps    • backache   • fatigue
• water-weight gain

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other information

STORAGE AND HANDLING SECTION

• 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)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

SPL UNCLASSIFIED SECTION

Maximum Strength 

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

OPOSITIV.COM
Distributed By: O Positiv, Inc.
11740 San Vicente Blvd Los Angeles, CA 90049

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O Positiv-489O Positiv-489

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN4
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD4
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83049-489-08FLO PMS Complete8 in 1 BLISTER PACKTABLET84
83049-489-08FLO PMS Complete3 in 1 CARTONTABLET34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83049-489FLO PMS COMPLETE (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET [O POSITIV, INC.]4Current NDC, Legacy NDC, 2 package rows20231010_cce62d9f-adb1-4473-8258-910dff6b1378.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83049-48983049-489-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLO PMS CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEO Positiv, Inc.cce62d9f-adb1-4473-8258-910dff6b13782023-10-09WarningsExact identifier
ndc (package): 83049-489-08
ndc (product): 83049-489
ndc11 (package): 83049048908
spl id: a0526808-00a6-42a5-aeb8-42db54626a28
spl set id: cce62d9f-adb1-4473-8258-910dff6b1378

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.