MENSTRUAL RELIEF- acetaminophen, caffeine and pyrilamine maleate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)

Available from:

TOP CARE (Topco Associates LLC)

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 500 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Diuretic Antihistamine - for the temporary relief of these symptoms associated with menstrual periods cramps bloating fatigue backache water-weight gain headache muscle aches - cramps - bloating - fatigue - backache - water-weight gain - headache - muscle aches

Authorization status:

OTC monograph not final

Summary of Product characteristics

MENSTRUAL RELIEF- ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE
TABLET
TOP CARE (TOPCO ASSOCIATES LLC)
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
DRUG FACTS
ACTIVE INGREDIENTS (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
fatigue
backache
water-weight gain
headache
muscle aches
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.
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
drowsiness may occur
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,