FDA.reportPublic FDA data

Dolex Fem

Manufacturer
Pharmadel LLC
Effective date
2026-02-05
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:44:24

Label at a glance#

ProductDolex Fem
Active ingredientACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Label structure8 sections

Indications and uses

For the temporary relief of these symptoms associated with menstrual periods cramps bloating water- weight gain headache backache Muscle aches fatigue

Dosage and administration

Do not exceed recommended dose adultos and children 12 years of age and over: take two (2) caplets, every 6 hours, do not exceed 6 caplets in a 24- hour period children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

.

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purposes
Acetaminophen 500mg............................Pain reliever
Caffeing 60mg .........................................Diuretic
Pyrilamine maleate 15mg.........................Anthistamine

Uses

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

WARNINGS SECTION

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

more than 6 tablets in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product.

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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 beat.

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 allergic to any of the ingredients in this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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 if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

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 7 days
  • fever gets worse or lasts more than 3 days

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 an 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 exceed recommended dose
  • adultos and children 12 years of age and over: take two (2) caplets, every 6 hours, do not exceed 6 caplets in a 24- hour period
  • children under 12 years of age: do not use

Other information

OTC - QUESTIONS SECTION

  • Store at room temperature 77-86°F (25-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

1-866-359-3478 (M-F) 9AM - 5PM or www.pharmadel.com

*This product is not manufactured or distributed by Bayer Healthcare LLC owner of the registered trademark MidolⓇ Complete.

Prinicpal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dolex fem pdpdolex fem pdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN13
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD13
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY13

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
55758-326-022025-07-31C16284748780-13b156c62-2f37-fb37-e063-e6dba90a4e07Dolex Fem (HHH)
55758-326-252025-07-31C16284748780-13b156c62-2f37-fb37-e063-e6dba90a4e07Dolex Fem (HHH)
55758-326-502025-07-31C16284748780-13b156c62-2f37-fb37-e063-e6dba90a4e07Dolex Fem (HHH)
55758-326-022025-07-29C16284748780-13b156c62-2f37-fb37-e063-e6dba90a4e07Dolex Fem (HHH)
55758-326-252025-07-29C16284748780-13b156c62-2f37-fb37-e063-e6dba90a4e07Dolex Fem (HHH)
55758-326-502025-07-29C16284748780-13b156c62-2f37-fb37-e063-e6dba90a4e07Dolex Fem (HHH)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-326-02Dolex Fem2 in 1 PACKETTABLET, COATED213
55758-326-25Dolex Fem1 in 1 CARTONTABLET, COATED113
55758-326-25Dolex Fem24 in 1 BLISTER PACKTABLET, COATED2413
55758-326-50Dolex Fem25 in 1 BOXTABLET, COATED2513

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-32655758-326-25, 55758-326-02, 55758-326-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POVIDONE K30U725QWY32XIACT
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB
TALC7SEV7J4R1UIACT

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
Dolex FemACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPharmadel LLCb1cab10b-19f1-f5d5-e053-2995a90a4d5f2026-02-05WarningsExact identifier
ndc (package): 55758-326-02
ndc (package): 55758-326-50
ndc (package): 55758-326-25
ndc (product): 55758-326
ndc11 (package): 55758032602
ndc11 (package): 55758032650
ndc11 (package): 55758032625
spl id: 4a169436-bb76-aceb-e063-6394a90a557f
spl set id: b1cab10b-19f1-f5d5-e053-2995a90a4d5f

Reported adverse events (FAERS/openFDA)#

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