NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY- 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 -  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 - 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 These could be signs of a serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY- ACETAMINOPHEN,
DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID
SALADO SALES, INC.
----------
NIGHT TIME CHERRY 502
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 4,000 mg of acetaminophen in 24 hours
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
to make a child sleepy
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