AMPIGRIN ULTRA FORTE NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

OPMX LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Temporarily relieves common cold/flu symptoms: - Cough due to minor throat & bronchial irritation - Sore throat - Headache - Minor aches & pains - Fever - Runny nose & sneezing

Authorization status:

OTC monograph final

Summary of Product characteristics

AMPIGRIN ULTRA FORTE NIGHT- ACETAMINOPHEN, DEXTROMETHORPHAN
HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED
OPMX LLC
----------
AMPIGRIN ULTRA FORTE - NIGHT
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_SOFTGELS)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever reducer
Dextromethorphan HBr 15 mg
Cough suppressant
Doxylamine succinate 6.25 mg
Antihistamine
USES
Temporarily relieves common cold/flu symptoms:
Cough due to minor throat & bronchial irritation
Sore throat
Headache
Minor aches & pains
Fever
Runny nose & sneezing
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take
more than 4 doses in 24 hrs, which is the maximum daily amount for
this product
with other drugs containing acetaminophen
3 or more alcoholic drinks daily 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
SORE THROAT WARNING
If sore throat is severe, lasts for more than 2 days, occurs with or
is followed by fever,
headache, rash, nausea, or vomiting, see a doctor promptly.
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
(MAOI) (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
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with
smoking, asthma,
chronic bronchitis or emphysema
trouble urinating due to enlarged prostate gland
WHEN USING THIS PRODUCT
Excitability may occur, especially in children
Marked d