NIGHTTIME COLD AND FLU- acetaminophen dextromethorphan hbr doxylamine succinate capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

WALGREENS

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Uses temporarily relieves common cold/flu symptoms: - cough due to minor throat & bronchial irritation - sore throat - headache - minor aches & pains - fever - runny nose & sneezing 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 depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Stop use and ask a doctor if - pain, or cough gets worse or lasts more than 7 days - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition

Authorization status:

OTC monograph final

Summary of Product characteristics

NIGHTTIME COLD AND FLU- ACETAMINOPHEN DEXTROMETHORPHAN HBR
DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED
WALGREENS
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NIGHTTIME COLD & FLU SOFTGELS
DRUG FACTS
_ACTIVE INGREDIENTS (IN EACH SOFTGEL)_
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
_PURPOSE_
Pain reliever/fever reducer
Cough suppressant
Antihistamine
_USES_ temporarily relieves common cold/flu symptoms:
cough due to minor throat & bronchial irritation
sore throat
headache
minor aches & pains
fever
runny nose & sneezing
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur
if you take
more than 4 doses in 24 hours, which is the maximum daily amount for
this product
with other drugs containing acetaminophen
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.
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 depression, psychiatric or emotional conditions, or
Parkinson's disease), or
for 2 weeks after stopping the MAOI drug. If you do not know if your
prescription
drug contains an MAOI, ask a doctor or pharmacist before taking this
product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with
smoking, asthma,
chronic bronchitis, or emphysema
trouble urinating due to enlarged prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers
taking the b