SYNCOL- acetaminophen, pamabrom, pyrilamine maleate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6), PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)

Available from:

MarcasUSA LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 500 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acetaminophen 500 mg ..........................................Pain reliever Pamabrom 25 mg ....................................................Diuretic Pyrilamine maleate15 mg........................................Antihistamine for the temporary relief of these symptoms associated with menstrual periods: - cramps - headache - bloating - backache - water-weight gain - muscular aches - irritability

Authorization status:

OTC monograph not final

Summary of Product characteristics

SYNCOL- ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE CAPSULE
MARCASUSA 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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SYNCOL
_DRUG FACTS_
_ACTIVE INGREDIENTS_ (IN EACH CAPLET)
_PURPOSE_
Acetaminophen 500 mg ..........................................Pain
reliever
Pamabrom 25 mg
....................................................Diuretic
Pyrilamine maleate15
mg........................................Antihistamine
_USES_
for the temporary relief of these symptoms associated with menstrual
periods:
cramps
headache
bloating
backache
water-weight gain
muscular aches
irritability
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. The maximum daily
dose
of this product is 6 caplets (3,000 mg) in 24 hours. 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:
rash
skin reddening
blisters
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.
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
avoid alcoholic beverages
drowsiness may occur
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving or operating machinery
STOP USE AND ASK A DOCTOR IF
redness or swelling is present
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