BC SINUS CONGESTION AND PAIN- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Medtech Products Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 650 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/Fever reducer Antihistamine Nasal decongestant - temporarily relieves these allergy and cold symptoms: • nasal and sinus congestion • minor aches and pains • itchy, watery eyes • itching of the nose and throat • runny nose • headache • sneezing - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

BC SINUS CONGESTION AND PAIN- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE,
PHENYLEPHRINE HYDROCHLORIDE POWDER
MEDTECH PRODUCTS INC.
_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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BC SINUS CONGESTION AND PAIN
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH POWDER)_
Acetaminophen 650 mg
Chlorpheniramine maleate 4mg
Phenylephrine hydrochloride 10mg
_PURPOSES_
Pain reliever/Fever reducer
Antihistamine
Nasal decongestant
_USES_
temporarily relieves these allergy and cold symptoms:
• nasal and sinus congestion
• minor aches and pains
• itchy, watery eyes
• itching of the nose and throat
• runny nose
• headache
• sneezing
temporarily reduces fever
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if you take
more than 5 powders in 24 hours, which is the maximum daily amount
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 are now taking a prescription monoamine oxidase inhibitor
(MOAI) (certain drugs for
depression, psychiatric, or emotional conditions, or Parkinson’s
disease), or for 2 weeks after
stopping the MAOI drug. If you do not know if your prescription drug
contains an MAOI, ask a
doctor or pharmacist before taking this product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
high blood pressure
diabetes
thyroid disease
glaucoma
heart disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
ASK A DOCTOR