ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE capsule, liquid filled

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Fáanlegur frá:

Granules India Limited

INN (Alþjóðlegt nafn):

PHENYLEPHRINE HYDROCHLORIDE

Samsetning:

PHENYLEPHRINE HYDROCHLORIDE 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

OTC DRUG

Ábendingar:

Pain reliever/fever reducer Cough suppressant Nasal decongestant • temporarily relieves these symptoms due to cold and flu: sneezing itching of the nose, throat or watery eyes due to hay fever cough nasal congestion sinus congestion and pressure sore throat head ache minor aches and pains • helps clear nasal passages and shrinks swollen membranes • temporarily reduces fever • 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. • if you ever had an allergic reaction to this

Leyfisstaða:

OTC monograph final

Vara einkenni

ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE
HYDROCHLORIDE- ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE
PHENYLEPHRINE
HYDROCHLORIDE CAPSULE, LIQUID FILLED
GRANULES INDIA LIMITED
_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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ACETAMINOPHEN 325 MG
DEXTROMETHORPHAN HYDROBROMIDE 10 MG
PHENYLEPHRINE HYDROCHLORIDE 5 MG
ACTIVE INGREDIENT
(in each Softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
PURPOS ES
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
US ES
• temporarily relieves these symptoms due to cold and flu:
sneezing
itching of the nose, throat or watery eyes due to hay fever
cough
nasal congestion
sinus congestion and pressure
sore throat
head ache
minor aches and pains
• helps clear nasal passages and shrinks swollen membranes
• temporarily reduces fever
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take
• more than 10 softgels 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 ALERT
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 allergic reaction occurs, stop use and seek medical help
right away.
SORE THROAT WARNING
If sore throat is severe, persists for more than 2 days, is
accompanied or followed by fever, headache,
rash, nausea or vomiting consult 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