MULTI SYMPTOM SEVERE COLD PE- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
18-11-2021

Aktiv bestanddel:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Tilgængelig fra:

VALU MERCHANDISERS COMPANY

Indgivelsesvej:

ORAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

- temporarily relieves these symptoms of the common cold: runny nose sneezing headache sore throat minor aches and pains nasal congestion cough - runny nose - sneezing - headache - sore throat - minor aches and pains - nasal congestion - cough - temporarily reduces fever

Autorisation status:

OTC monograph final

Produktets egenskaber

                                MULTI SYMPTOM SEVERE COLD PE- ACETAMINOPHEN, DIPHENHYDRAMINE
HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED
VALU MERCHANDISERS COMPANY
_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._
----------
1124-BST-2021-1117
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever
reducer
Diphenhydramine HCl 12.5 mg
Antihistamine/cough
suppressant
Phenylephrine HCl 5 mg
Nasal decongestant
USES
temporarily relieves these symptoms of the common cold:
runny nose
sneezing
headache
sore throat
minor aches and pains
nasal congestion
cough
temporarily reduces fever
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take
more than 12 caplets 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
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.
with any other product containing diphenhydramine, even one used on
skin
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
diabetes
heart disease
high blood pressure
thyroid disease
glaucoma
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or
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