DAYTIME NON-DROWSY COLD/FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride 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), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Salado Sales, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg in 15 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant Uses temporarily relieves these common cold/flu symptoms: - minor aches and pains ● headache ● sore throat ● fever - nasal congestion ● cough due to minor throat and bronchial irritation Do not use • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists. Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur ● fever gets worse or lasts more than 3 days ● pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • redness or swelling is present ● cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

DAYTIME NON-DROWSY COLD/FLU- ACETAMINOPHEN, DEXTROMETHORPHAN
HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID
SALADO SALES, INC.
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_DRUG FACTSACTIVE INGREDIENTS (IN EACH 15 ML, 1 TABLESPOON)_
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCL 5 mg
_PURPOSE_
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
_USES _temporarily relieves these common cold/flu symptoms:
minor aches and pains ● headache ● sore throat ● fever
nasal congestion ● cough due to minor throat and bronchial
irritation
_WARNINGS_
LIVER WARNING: The product contains acetaminophen. Severe liver
damage may occur if ■ adult takes more than 4doses (30 mL each)
in 24 hours, which is the maximum daily amount for this product ■
child takes more than 4 doses (15 mL each) in 24 hours, which is the
maximum daily amount for this product ■ taken with other drugs
containing acetaminophen ■ adult has 3 or more alcoholic drinks
every day while using the 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 • 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 two
weeks after stopping
the MAOI drug. If you do not know if your prescription drug contains
an MAOI, ask a
doctor or a
pharmacist before taking this product.
• with any other drug containing acetaminophen (prescription or
non-prescription). If
you are not
sure whether a drug contains acetaminophen, ask a doctor or
pharmacists.
ASK A DOCTOR BEFORE USE IF YOU HAVE • liver disease • heart
disease •thyroid disease
diabetes • high blood pressure • trouble urinating due to enlarged
prostat