FDA.reportPublic FDA data

MENSTRUAL COMPLETE

Manufacturer
Allegiant Health
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:38:30

Label at a glance#

ProductMENSTRUAL COMPLETE
Active ingredientACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Label structure9 sections

Dosage and administration

■ do not take more than directed ■ 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

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg 
Caffeine 60 mg 
Pyrilamine maleate 15 mg 

Purpose

OTC - PURPOSE SECTION

Pain reliever
Diuretic
Antihistamine

Use(s)

INDICATIONS & USAGE SECTION

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

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

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.

■ if you have ever had an allergic reaction to this product or
any of its ingredients

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase
drowsiness ■ avoid alcoholic beverages
■ excitability may occur, especially in children
■ use caution when driving a motor vehicle or operating
machinery
■ 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 heart rate. The recommended dose
of this product contains about as much caffeine as a cup of
coffee.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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 breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.
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 directed
■ 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

SPL UNCLASSIFIED SECTION

■ store at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F) ■ use by expiration date on package

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/Comments

OTC - QUESTIONS SECTION

1-888-952-0050

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Menstrual Complete
Menstrual Complete

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN2
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD2
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY2

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
69168-470-06MENSTRUAL COMPLETE120 in 1 BOTTLETABLET, FILM COATED1202
69168-470-82MENSTRUAL COMPLETE90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-470MENSTRUAL COMPLETE TABLET, FILM COATED [ALLEGIANT HEALTH]2Current NDC, 2 package rows20241122_d197b886-67e4-4aba-8582-305576c07604.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-47069168-470-82, 69168-470-06

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

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
MENSTRUAL COMPLETEMENSTRUAL COMPLETEAllegiant Healthd197b886-67e4-4aba-8582-305576c076042024-11-05WarningsExact identifier
ndc (package): 69168-470-06
ndc (package): 69168-470-82
ndc (product): 69168-470
ndc11 (package): 69168047006
ndc11 (package): 69168047082
spl id: 6e554ca0-5318-4b25-a548-e0a74b3dcb16
spl set id: d197b886-67e4-4aba-8582-305576c07604

Reported adverse events (FAERS/openFDA)#

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