COOLING SEVERE DAYTIME COOLING SEVERE NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephri

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

MAH:

CVS Pharmacy

prescription_type:

OTC DRUG

therapeutic_indication:

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant temporarily relieves common cold/flu symptoms: Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant temporarily relieves common cold/flu symptoms: taking the blood thinning drug warfarin

authorization_status:

OTC monograph final

SPC

COOLING SEVERE DAYTIME COOLING SEVERE NIGHTTIME- ACETAMINOPHEN,
DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE
HYDROCHLORIDE,GUAIFENESIN
CVS PHARMACY
_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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CVS PHARMACY, INC. COOLING SEVERE DAYTIME COOLING SEVER NIGHTTIME DRUG
FACTS
ACTIVE INGREDIENTS (IN EACH 30 ML) – NIGHT TIME
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
PURPOS E
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
US ES
temporarily relieves common cold/flu symptoms:
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WARNINGS
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if you take
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nasal congestion
sinus congestion and pressure
minor aches and pains
headache
sore throat
runny nose and sneezing
cough to help you sleep
cough due to minor throat and bronchial irritation
reduces swelling of nasal passages
fever
promotes nasal and/or sinus drainage
temporarily restores freer breathing through the nose
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
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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.
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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3 or more alcoholic drinks every day while using this product
skin reddening
blisters
rash
with any other drug containing acetaminophen (prescription or
nonprescription).