FDA Label for Medi First Plus Pms Relief
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Medi First Plus Pms Relief Product Label
The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg
Otc - Purpose
Purpose
Pain reliever
Diuretic
Antihistamine
Indications & Usage
Uses
for the temporary relief of these symptoms associated with menstrual periods:
■ headache
■ bloating
■ cramps
■ backache
■ muscular aches
■ irritability
■ water-weight gain
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use
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
Otc - Ask Doctor
Ask a doctor before use if you have
■ difficulty in urination due to enlargement of the prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ liver disease
■ glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
■ taking sedatives or tranquilizers
■ taking the blood thinning drug warfarin
Otc - When Using
When using this product
■ drowsiness may occur
■ avoid alcoholic beverages
■ excitability may occur, especially in children
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ use caution when driving a motor vehicle or operating machinery
Otc - Stop Use
Stop use and ask a doctor if
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
Directions
■ do not take more than directed
Adults and children: (12 years and over)
■ take 2 caplets with water every 6 hours as needed
■ do not exceed 6 caplets in a 24 hour period or as directed by a doctor
Children under 12 years: ask a doctor
Other Safety Information
Other information
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ tamper-evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide
Otc - Questions
Questions or comments? 1-800-634-7680
Package Label.Principal Display Panel
Medi-First®
PMS Relief
Pain Reliever • Acetaminophen 500 mg
Diuretic • Pamabrom 25 mg
Antihistamine • Pyrilamine maleate 15 mg
Mestrual Pain Relief
Pull to Open
This Package is for Households Without Young Children.
Tamper Evident Unit Dose Packets
80 Caplets
(40 x 2)
Medi-First®Plus
PMS Relief
Pain Reliever • Acetaminophen 500 mg
Diuretic • Pamabrom 25 mg
Antihistamine • Pyrilamine maleate 15 mg
This Package is for Households Without Young Children.
Pull to Open
Relief from Menstrual Pain, Water Retention and Bloating
Tamper Evident Unit Dose Packets
80 Caplets
(40 x 2's)
* Please review the disclaimer below.