COLD AND FLU NIGHT TIME MULTI-SYMPTOM RELIEF ORIGINAL- acetaminophen, dextromethorphan hbr, 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:

Pharmacy Value Alliance, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Acetaminophen                 Pain reliever/fever reducer Dextromethorphan HBr     Cough suppressant Doxylamine Succinate       Antihistamine Uses temporarily relieves cold/flu symptoms: • sore throat • headache • minor aches and pain • fever • runny nose and sneezing • cough due to minor throat and bronchial irritation 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 Stop use and ask a doctor if • 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, or headache that lasts. These could be signs of a serious condition.

Authorization status:

OTC monograph final

Summary of Product characteristics

COLD AND FLU NIGHT TIME MULTI-SYMPTOM RELIEF ORIGINAL-
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE LIQUID
PHARMACY VALUE ALLIANCE, LLC
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COLD & FLU NIGHT-TIME MULTI-SYMPTOM RELIEF
_DRUG FACTS_
ACTIVE INGREDIENTS (IN EACH 30 ML DOSE CUP)
Acetaminophen 650 mg
Dextromethorphan HBr 30mg
Doxylamine Succinate 12.5 mg
_PURPOSE_
Acetaminophen Pain reliever/fever reducer
Dextromethorphan HBr Cough suppressant
Doxylamine Succinate Antihistamine
_USES _temporarily relieves cold/flu symptoms: • sore throat •
headache
• minor aches and pain • fever • runny nose and sneezing
• cough due to minor throat and bronchial irritation
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if you take
• more than 4,000 mg of Acetaminophen in 24 hours, which is the
maximum daily
amount
• 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 askin reaction occurs, stop use and seek medical help right away.
SORE THROAT WARNING: If sore throat is severe, persists for more than
two 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 o