TOPCARE COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Køb det nu

Hent Produktets egenskaber (SPC)
17-01-2018

Aktiv bestanddel:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Tilgængelig fra:

Topco Associates LLC

Indgivelsesvej:

ORAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

Autorisation status:

OTC monograph final

Produktets egenskaber

                                TOPCARE COLD- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE,
DEXTROMETHORPHAN HBR,
PHENYLEPHRINE HCL SUSPENSION
TOPCO ASSOCIATES LLC
_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._
----------
TOPCO ASSOCIATES LLC. CHILDREN’S PAIN RELIEF PLUS MULTI-SYMPTOM COLD
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 5 ML)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
PURPOS ES
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
US ES
•
•
•
•
•
•
•
•
•
•
•
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if your child takes
•
•
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms
may include:
•
temporarily relieves
minor aches and pains
headache
minor sore throat pain
runny nose
itchy nose or throat
sneezing
itchy, watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a
cold
temporarily reduces fever
more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
skin reddening
•
•
If a skin 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
•
•
•
•
•
ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
•
•
•
•
•
•
•
•
•
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS TAKING
•
•
WHEN USING THIS PRODUCT
•
•
•
•
STOP USE AND ASK A DOCTOR IF
•
•
•
•
blisters
rash
in a child under 4 years of age
if your child has ever had an allergic reaction to this product or any
of its ingredients
with any other drug containing acetaminophen (prescription or
nonprescription)
                                
                                Læs hele dokumentet