MedPath

Dolex Fem

Dolex Fem (Health Pharma)

Approved
Approval ID

b1cab10b-19f1-f5d5-e053-2995a90a4d5f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

Pharmadel LLC

DUNS: 030129680

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Caffeine, Pyrilamine Maleate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55758-326
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Caffeine, Pyrilamine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (14)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CAFFEINEActive
Quantity: 60 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
PYRILAMINE MALEATEActive
Quantity: 15 mg in 1 1
Code: R35D29L3ZA
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/13/2023

Prinicpal Display Panel

dolex fem pdp

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/1/2020

Uses

For the temporary relief of these symptoms associated with menstrual periods

  • cramps
  • bloating
  • water- weight gain
  • headache
  • backache
  • Muscle aches
  • fatigue

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/9/2021

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/9/2021

Active ingredients & Purposes

.

Active ingredients (in each tablet)

Purposes

Acetaminophen 500mg............................

Pain reliever

Caffeing 60mg .........................................

Diuretic

Pyrilamine maleate 15mg.........................

Anthistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 4/13/2023

Warnings

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

more than6 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

  • with any other drug containingacetaminophen (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

  • 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

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

When using this product

  • 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

  • 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,

ask a health professional before use.

Keep out of reach of children.

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/1/2020

Directions

*Do not exceed recommended dose *adultos and children 12 years of age and over:take two (2) caplets, every 6 hours, do not exceed6 caplets in a 24- hour period *children under 12 years of age: do not use

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/1/2020

Questions or comments?

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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/1/2020

Inactive ingredients

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

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