COLD/FLU MULTI-SYMPTOM RELIEF DAYTIME/NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hc

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:

DOLGENCORP, LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Cough suppressant Nasal decongestant Pain reliever/fever reducer Antihistamine Nasal decongestant - temporarily relieves these common cold and flu symptoms: - headache - nasal congestion  - sore throat (Daytime only) - cough (Daytime only) - minor aches and pains  - sinus congestion and pressure - runny nose and sneezing (Nighttime only) - helps clear nasal passages  - promotes nasal and sinus drainage - temporarily reduces fever  - temporarily relieves these additional symptoms of hay fever or other upper respiratory allergies: (Nighttime only) itching of the nose or throat (Nighttime only) itchy, watery eyes (Nighttime only) - itching of the nose or throat (Nighttime only) - itchy, watery eyes (Nighttime only)

Authorization status:

OTC monograph final

Summary of Product characteristics

COLD/FLU MULTI-SYMPTOM RELIEF DAYTIME/NIGHTTIME- ACETAMINOPHEN,
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
DOLGENCORP, 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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REXALL 44-559-560 DELISTED
_ACTIVE INGREDIENTS (IN EACH GELCAP) (DAYTIME COLD MULTI-SYMPTOM)_
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
_​ACTIVE INGREDIENTS (IN EACH GELCAP) (NIGHTTIME FLU RELIEF)_
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg
_PURPOSE _
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
_USES_
temporarily relieves these common cold and flu symptoms:
headache
nasal congestion
sore throat (DAYTIME ONLY)
cough (DAYTIME ONLY)
minor aches and pains
sinus congestion and pressure
runny nose and sneezing (NIGHTTIME ONLY)
helps clear nasal passages
promotes nasal and sinus drainage
temporarily reduces fever
temporarily relieves these additional symptoms of hay fever or other
upper
respiratory allergies: (NIGHTTIME ONLY)
itching of the nose or throat (NIGHTTIME ONLY)
itchy, watery eyes (NIGHTTIME ONLY)
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur
if you take
with other drugs containing acetaminophen
more than 4,000 mg of acetaminophen in 24 hours
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, persists for more than
2 days, is
accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly. (DAYTIME ONLY)
DO NOT USE
with any other drug containing acetaminophen (prescription or
nonpresc