Premsyn pms Premenstrual Pain Relief

Manufacturer
Focus Consumer Healthcare, LLC
Effective date
2025-04-14
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:59:09

Label at a glance#

ProductPremsyn pms Premenstrual Pain Relief
Active ingredientACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

(in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

OTC - PURPOSE SECTION

Pain reliever

Antihistamine

Diuretic

INDICATIONS & USAGE SECTION

For the temporary relief of these symptoms associated with menstrual periods:

  • cramps
  • headache
  • bloating
  • backache
  • water-weight gain
  • muscular aches
  • irritability

WARNINGS SECTION

Allergy Warning: 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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 caplets in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product



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.

Ask a doctor before use if you have:

  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargment of the prostate gland.

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 beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving or operating machinery
  • excitability may occur, especially in children

stop use and ask doctor if:

  • Pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • If pregnant or breastfeeding, ask a health professional before use.

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

you have

  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are

  • taking the blood thinning drug warfarin 
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • you may get drowsy, avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over:

  • take 2 caplets with water every 6 hours as needed
  • do not exceed 8 caplets in a 24 hour period or as directed by a doctor
  • do not use more than directed (see warnings)

children under 12 years: ask a doctor

INACTIVE INGREDIENT SECTION

blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregalatinized starch, propylaparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052637acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral TabletPSN8
1052641Premsyn PMS 500 MG / 25 MG / 15 MG Oral TabletPSN8
1052641acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet [Premsyn PMS]SBD8
1052637acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral TabletSCD8
1052637APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral TabletSY8
1052641APAP 500 MG / pamabrom 25 MG / Pyrilamine Maleate 15 MG Oral Tablet [Premsyn PMS]SY8
1052641Premsyn PMS (APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG) Oral TabletSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71687-3102-42025-04-14C16284748780-12cef2736-8f8b-d83d-e063-dadaa90ab31fPremsyn pms Premenstrual Pain Relief
71687-3102-42025-01-30C16284748780-12cef2736-8f8b-d83d-e063-dadaa90ab31fPremsyn pms Premenstrual Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71687-3102-4Premsyn pms Premenstrual Pain Relief40 in 1 BOTTLE, PLASTICTABLET408
71687-3102-4Premsyn pms Premenstrual Pain Relief1 in 1 CARTONTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71687-3102PREMSYN PMS PREMENSTRUAL PAIN RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [FOCUS CONSUMER HEALTHCARE, LLC]8Current NDC, Legacy NDC, 2 package rows20250416_5b6f6260-69ae-cfeb-e053-2a91aa0a6b49.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71687-310271687-3102-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Premsyn pms Premenstrual Pain ReliefACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATEFocus Consumer Healthcare, LLC5b6f6260-69ae-cfeb-e053-2a91aa0a6b492025-04-14WarningsExact identifier
ndc (package): 71687-3102-4
ndc (product): 71687-3102
ndc11 (package): 71687310204
spl id: 32bde825-4a2d-de16-e063-6394a90a7941
spl set id: 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49

Reported adverse events (FAERS/openFDA)#

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