COLD AND FLU NIGHTTIME RELIEF- acetaminophen, doxylamine succinate, and dextromethorphan hbr solution

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:

Fred's, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 650 mg in 30 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Active ingredients (in each 30 mL dose cup)                   Purpose Acetaminophen, USP 650 mg ........................................... Pain reliever/fever reducer Dextromethorphan HBr, USP 30 mg ........................................... Cough suppressant Doxylamine succinate, USP 12.5 mg .................................................... Antihistamine temporarily relieves common cold/flu symptoms: - cough due to minor throat and bronchial irritation - sore throat - headache - minor aches and pains - fever - runny nose and sneezing - 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 pharmacis

Authorization status:

OTC monograph final

Summary of Product characteristics

COLD AND FLU NIGHTTIME RELIEF - ACETAMINOPHEN, DOXYLAMINE SUCCINATE,
AND
DEXTROMETHORPHAN HBR SOLUTION
FRED'S, INC.
_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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DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 30 ML DOSE CUP) PURPOSE
Acetaminophen, USP 650 mg ...........................................
Pain reliever/fever reducer
Dextromethorphan HBr, USP 30 mg
........................................... Cough suppressant
Doxylamine succinate, USP 12.5 mg
.................................................... Antihistamine
US ES
temporarily relieves common cold/flu symptoms:
cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
runny nose and sneezing
WARNINGS
LIVER WARNING: THIS PRODUCT CONTAINS ACETAMINOPHEN.
Severe liver damage may occur if you take
more than 4 doses (120 mL) 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, lasts for more than 2
days, occurs with or is followed by
fever, headache, rash, nausea, or vomiting, see 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 sl