Topco Associates LLC. Cold & Flu Night Time Drug Facts

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Topco Associates LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Antihistamine Nasal decongestant These could be signs of a serious condition.

Authorization status:

OTC monograph final

Summary of Product characteristics

TOPCARE COLD AND FLU NIGHT TIME- ACETAMINOPHEN, DIPHENHYDRAMINE HCL,
PHENYLEPHRINE HCL TABLET, FILM COATED
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._
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TOPCO ASSOCIATES LLC. COLD & FLU NIGHT TIME DRUG FACTS
ACTIVE INGREDIENTS (IN EACH CAPLET)
Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg
PURPOS ES
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
US ES
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if you take
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Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms
may include:
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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.
temporarily relieves these common cold and flu symptoms:
nasal congestion
headache
minor aches and pains
sore throat
runny nose and sneezing
temporarily reduces fever
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
skin reddening
blisters
rash
by fever, headache, rash, nausea, or vomiting, consult a doctor
promptly.
DO NOT USE
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ASK A DOCTOR BEFORE USE IF YOU HAVE
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
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WHEN USING THIS PRODUCT
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STOP USE AND ASK A DOCTOR IF
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These could be signs of a serious condition.
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 taki