DayTime Cold and Flu Relief Acetaminophen, Dextromethorphan and Phenylephrine

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HealthLife of USA

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Cough suppressant Nasal decongestant temporarily relieves common cold/flu symptoms: - nasal congestion - cough due to minor throat and bronchial irritation - sore throat - headache - minor aches and pains - fever

Authorization status:

OTC monograph final

Summary of Product characteristics

DAYTIME COLD AND FLU RELIEF- ACETAMINOPHEN, DEXTROMETHORPHAN,
PHENYLEPHRINE CAPSULE, LIQUID FILLED
HEALTHLIFE OF USA
_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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DAYTIME COLD AND FLU RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN AND
PHENYLEPHRINE
ACTIVE INGREDIENT
(IN EACH SOFTGEL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
PURPOS E
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
US ES
temporarily relieves common cold/flu symptoms:
nasal congestion
cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
WARNINGS
LIVER WARNING: This product contains acetaminophen. 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:
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, 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) (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 have ever had an allergic reaction to this product or any of
its ingredients
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
heart disease
thyroid dise