FDA Label for Menstrual Relief
View Indications, Usage & Precautions
Menstrual Relief Product Label
The following document was submitted to the FDA by the labeler of this product Velocity Pharma. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
(in each caplet)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine Maleate 15 mg
Purpose
Pain Reliever
Diuretic
Antihistamine
Uses
For the temporary relief of these symptoms associated with menstrual periods:
- Cramps
- Bloating
- Water-weight gain
- Headache
- Backache
- Muscle aches
- Fatigue
Warnings
SEE BOTTLE FOR ADDITIONAL WARNINGS AND PRODUCT INFORMATION.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- More than 6 caplets in 24 hours, which is the maximum daily amount for this product
- With other drug containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- 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.
- Liver disease
- Glaucoma
- Difficulty in urination due to enlargement of the prostate gland
- A breathing problem such as emphysema or chronic bronchitis
- 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 as a cup of coffee.
Stop use and ask a doctor if:
- 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
If pregnant or breast feeding ask a health professional before use.
Do not use:
Ask a doctor before use if you have:
Ask a doctor or pharmacist before use if you are:
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center 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 take more than the recommended dose
- Adults and Children 12 years and older:
- 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
- Store at a controlled temperature between 62 and 77 degrees F
Inactive Ingredients
Carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, micro-crystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin
Questions?
Call 1-855-314-1850
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Velocity Pharma LLC
Package Label.Principal Display Panel
NDC: 76168-064-03 –20 COUNT
Enteric Coated to help prevent upset stomach
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