Other
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Green Guard Cramp Relief (NDC 47682-049). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg
Purpose
Pain reliever
Diuretic
Antihistamine
Uses
for the temporary relief of these symptoms associated with menstrual periods:
■ headache
■ bloating
■ cramps
■ backache
■ muscular aches
■ irritability
■ water-weight gain
Warnigs
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.
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
■ difficulty in urination due to enlargement of the prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ liver disease
■ glaucoma
Ask a doctor or pharmacist before use if you are
■ taking sedatives or tranquilizers
■ taking the blood thinning drug warfarin
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
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.
If pregnant or breast-feeding, ask a health professional before use.
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.
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 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 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
Questions or comments? 1-800-869-6970
Menstrual Cramp Relief™
Pull to Open
Tire Para Abrir
Acetaminophen 500 mg / Acetaminofeno 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg / Maleato de pirilamina 15 mg
Green Guard®
Relief of menstrual pain, water retention and bloating
Para el alivio de dolores menstruales,
retencion de liquidos e hinchazon
40 Packets of 2 Caplets
80 Caplets
Order #2380
Distributed by Green Guard®
St Louis, MO 63045
* Please review the disclaimer below.