NITE-TIME COLD/FLU ORIGINAL- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

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), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)

Available from:

Salado Sales, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 650 mg in 30 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer   Cough suppressant   Antihistamine    temporarily relieves cold/flu symptoms: - sore throat - minor aches and pain - runny nose and sneezing - cough due to minor sore throat and bronchial irritation - headache - fever - a sodium restricted diet - 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 - if you are taking sedatives or tranquilizers - if you are taking the blood thinning drug warfarin - redness or swelling is present - symptoms do not get better within 7 days or are accompanied by a fever - fever gets worse or lasts more than 3 days - new symptoms occur - cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts - 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 - to make a child sleepy

Authorization status:

OTC monograph not final

Summary of Product characteristics

NITE-TIME COLD/FLU ORIGINAL- ACETAMINOPHEN, DEXTROMETHORPHAN
HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID
SALADO SALES, INC.
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NITE TIME 501
DRUG FACTSACTIVE INGREDIENTS (IN EACH 30 ML DOSE CUP)
Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate
12.5
mg
PURPOSE
Pain reliever/fever reducer
Cough suppressant
Antihistamine
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN.
USES
temporarily relieves cold/flu symptoms:
sore throat
minor aches and pain
runny nose and sneezing
cough due to minor sore throat and bronchial irritation
headache
fever
WARNINGS
FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES
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 amoun
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 ccurs, 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.
ASK A DOCTOR BEFORE USE IF YOU HAVE
a sodium restricted diet
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
if you are taking the blood thinning drug warfarin
WHEN USING THIS PRODUCT
DO NOT USE MORE THAN DIRECTED
avoid alcoholic drinks
excitability may occur, especially in children
marked drowsiness may occur
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
STOP USE AND ASK A DOCTOR IF
redness or swelling is present
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