Active Ingredients
Acetaminophen 500mg
Caffeine 60mg
Pyrilamine maleate 15mg
Dolex Fem Tablet, Coated
FDA Label NDC 55758-326
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Dolex Fem (NDC 55758-326). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief
Uses
- For the temporary relief of these symptoms associated with menstrual periods
- Cramps
- Bloating
- Water- weight gain
- Headache
- Backache
- Muscle aches
- Fatigue
Warnings
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.
- skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
Allergy warning: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
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 aboout as much caffeine as a cup of coffee.
Stop Use And Ask A Doctor If
- new symptoms appear
- 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.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- Do not exceed recommended dosage.
- Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day
- Children under 12 years: Consult a doctor
Other Information
- Store at room temperature
- TAMPER EVIDENT; DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients
- Colloidal silicon dioxide
- Hypromellose
- Magnesium stearate
- Microcrystalline cellulose
- Polyethylene glycol
- Polyvinyl pyrrolidone
- Pregelatinized starch
- Titanium dioxide
- Talc
Questions Or Comments?
1-866-359-3478 (M-F) 9AM - 5PM or www.pharmadel.com
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