Dolex Fem
Dolex Fem (Health Pharma)
b1cab10b-19f1-f5d5-e053-2995a90a4d5f
HUMAN OTC DRUG LABEL
Jul 30, 2025
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
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Prinicpal Display Panel
INDICATIONS & USAGE SECTION
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
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients & Purposes
.
Active ingredients (in each tablet) |
Purposes |
Acetaminophen 500mg............................ |
Pain reliever |
Caffeing 60mg ......................................... |
Diuretic |
Pyrilamine maleate 15mg......................... |
Anthistamine |
WARNINGS SECTION
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
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
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
Inactive ingredients
corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, titanium dioxide, water