Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg

Manufacturer
OPMX LLC
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:47

Label at a glance#

ProductAcetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg
Active ingredientCAFFEINE, PYRILAMINE MALEATE, ACETAMINOPHEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Caffeine 60mg

Pyrilamine maleate 15mg

INACTIVE INGREDIENT SECTION

ammonium hydroxide, croscarmellose sodium, D&C red No. 33 aluminum lake, ethyl cellulose, FD&C blue No. 1 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, light mineral oil, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch, propylene glycol, shellac glaze, sorbitol sorbitan, talc, titanium dioxide, triacetin

DOSAGE & ADMINISTRATION SECTION

  • Do not take more than the recommended dose
  • Adults and children 12 years and over: take 2 gelcaps with water, repeat every 6 hours, as needed; do not exceed 6 gelcaps per day
  • Children under 12 years: consult a doctor

INDICATIONS & USAGE SECTION

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

Cramps, bloating water-weight gain, headache, backache, muscle aches, fatigue.

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 gelcaps in 24 hours, which is the maximum daily amount for this product, with other drugs contains acetaminophen, 3 or more alcoholic drinks every day while using this product.

Allergy alert: Acetaminophen may cause severe skin reactions or severe allergic reactions. Symptoms may include: skin reddening, blisters, rash, hives, 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 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.

Stop use and ask a doctor if new symptoms occur, redness or swelling is present, pain gets worse or lasts for more than 10 days, fever gets worse or lasts for more than 3 days.

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

Overdose Warning: 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 - PURPOSE SECTION

Pain reliever

Nighttime sleep-aid

OTHER SAFETY INFORMATION

Store at room temperature between 20-25 ºC (68-77 ºF)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BuscompositumBuscompositum

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN1
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD1
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-145-222022-01-28C16284748780-1d6a99b39-6514-a426-e053-dadaa90af4c2Buscompositum Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-145-22Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg12 in 1 PACKAGETABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-145ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG TABLET [OPMX LLC]1Legacy NDC, 1 package rows20201117_b43f17f1-6dae-ffeb-e053-2a95a90a8708.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-14569729-145-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
b43f17f1-6dad-ffeb-e053-2a95a90a8708b43f17f1-6dae-ffeb-e053-2a95a90a87082020-11-16WarningsExact identifier
spl id: b43f17f1-6dad-ffeb-e053-2a95a90a8708
spl set id: b43f17f1-6dae-ffeb-e053-2a95a90a8708

Reported adverse events (FAERS/openFDA)#

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