SANAFLU XTRA- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

GRANDALL DISTRIBUTING, LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 250 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever - fever reducer Antihistamine Cough Suppressant Nasal Decongestant - Temporarily relives - minor aches and pains - headache - runny nose - sneezing - nasal congestion - itchy, watery eyes due to hay fever or other upper respiratory allergies - itching of the nose or throat - cough due to minor throat and bronchial irritation as may occur with the common cold ro inhaled irritants - Temperarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

SANAFLU XTRA- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE,
DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE,
GELATIN COATED
GRANDALL DISTRIBUTING, LLC
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GRANDALL (AS PLD) - SANAFLU XTRA (48201-001)
ACTIVE INGREDIENTS (IN EACH CAPSULE)
Acetaminophen 250 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
PURPOSES
Pain reliever - fever reducer
Antihistamine
Cough Suppressant
Nasal Decongestant
USES
Temporarily relives
minor aches and pains
headache
runny nose
sneezing
nasal congestion
itchy, watery eyes due to hay fever or other upper respiratory
allergies
itching of the nose or throat
cough due to minor throat and bronchial irritation as may occur with
the common
cold ro inhaled irritants
Temperarily reduces fever
WARNINGS
LIVER WARNINGThis 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.
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 monamine 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.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
a breathing problem such as emphysema or chronic bronchitis
glaucoma
heart disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
persistant or chrnoic cough such as occurs with smoking, asthma, or
emphysema
cough accompanied by excessive phlegm
thyroid disease
diabetes
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin
taking sedativies or tranquilizers
WHEN USING THIS PRODUCT
DO N