GUAIFENESIN AND CODEINE PHOSPHATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Available from:

PAI Holdings, LLC

INN (International Name):

GUAIFENESIN

Composition:

GUAIFENESIN 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants - helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN AND CODEINE PHOSPHATE- GUAIFENESIN AND CODEINE
PHOSPHATE SOLUTION
PAI HOLDINGS, LLC
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GUAIFENESIN AND CODEINE PHOSPHATE
_DRUG FACTS_
_ACTIVE INGREDIENTS IN EACH 5 ML (TEASPOONFUL)_
_PURPOSES_
Codeine Phosphate, USP 10 mg
Cough Suppressant
Guaifenesin, USP 100 mg
Expectorant
USES
temporarily relieves cough due to minor throat and bronchial
irritations as may occur
with the common cold or inhaled irritants
helps loosen phlegm (mucus) and thin bronchial secretions to make
cough more
productive
WARNINGS
DO NOT USE
in adults and children who have a chronic pulmonary disease or
shortness of breath,
or children who are taking other drugs, unless directed by a doctor.
ASK A DOCTOR BEFORE USE IF YOU HAVE
a cough with too much phlegm (mucus)
a persistent or chronic cough as occurs with smoking, asthma, chronic
bronchitis, or
emphysema
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives,
tranquilizers
and drugs used for depression, especially monoamine oxidase inhibitors
(MAOIs). These
combinations may cause greater sedation (drowsiness) than is caused by
the product
used alone.
STOP USE AND ASK A DOCTOR IF
cough lasts for more than 7 days, comes back, or occurs with fever,
rash or
headache that lasts. These can be signs of a serious condition.
may cause or aggravate constipation
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, seek
professional
assistance or contact a Poison Control Center immediately.
Use of codeine-containing preparation is not recommended for children
under 2
years of age.
DIRECTIONS
take every 4 hours
do not exceed 6 doses in 24 hours
a special measuring device should be used to give an accurate dose of
this product
to children under 6 years of age
giving a higher dose than recommended by a doctor can result in
serious side effects
for a child
adults and children 12 years and over10 mL (2 teaspoonfuls)
children 6 to under 12 years of age
5 mL (1 teaspoonful)
children under 6 years of ag