COLD HEAD CONGESTION DAYTIME / NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephr

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:

AAA Pharmaceutical, Inc.

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these common cold symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure - minor aches and pains - headache - sore throat - nasal congestion - cough - sinus congestion and pressure - helps clear nasal passages - temporarily relieves these common cold symptoms: minor aches and pains headache sore throat nasal congestion runny nose and sneezing cough sinus congestion and pressure - minor aches and pains - headache - sore throat - nasal congestion - runny nose and sneezing - cough - sinus congestion and pressure - helps clear nasal passages - relieves cough to help you sleep

Authorization status:

OTC monograph final

Summary of Product characteristics

COLD HEAD CONGESTION DAYTIME / NIGHTTIME- ACETAMINOPHEN,
CHLORPHENIRAMINE
MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE
HYDROCHLORIDE
AAA PHARMACEUTICAL, INC.
_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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COLD HEAD CONGESTION DAYTIME / NIGHTTIME 1162
COLD
HEAD CONGESTION
DAY
_DRUG FACTS_
_ACTIVE INGREDIENTS _
_(IN EACH DAY CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever
Dextromethorphan HBr 10 mg
Cough
suppressant
Phenylephrine HCl 5 mg
Nasal
decongestant
US ES
temporarily relieves these common cold symptoms:
minor aches and pains
headache
sore throat
nasal congestion
cough
sinus congestion and pressure
helps clear nasal passages
COLD
HEAD CONGESTION
NIGHT
_DRUG FACTS_
_ACTIVE INGREDIENTS _
_(IN EACH NIGHT CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever
Chlorpheniramine maleate 2 mg
Antihistamine
Dextromethorphan HBr 10 mg
Cough
suppressant
Phenylephrine HCl 5 mg
Nasal
decongestant
US ES
temporarily relieves these common cold symptoms:
minor aches and pains
headache
sore throat
nasal congestion
runny nose and sneezing
cough
sinus congestion and pressure
helps clear nasal passages
relieves cough to help you sleep
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.
if you are now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain drugs for