BUSCAPINA- acetaminophen, caffeine, pyrilamine maleate tablet, coated

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:

OPMX LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 500 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief - For the temporary relief of these symptoms associated with menstrual periods - Cramps - Bloating - Water- weight gain - Headache - Backache - Muscle aches - Fatigue - 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 - 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

BUSCAPINA- ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE TABLET, COATED
OPMX 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._
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BUSCAPINA
DRUG FACTS
Buscapina
ACTIVE INGREDIENTS (IN EACH CAPLET)
Acetaminophen 500mg, Caffeine 60mg, and Pyrilamine maleate 15mg
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.
Allergy warning: Acetaminophen may cause severe skin or severe
allergic reactions.
Symptoms may include:
skin reddening
blisters
rash
hives
facial swelling
asthma (wheezing)
shock
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 caffe