CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antitussive Expectorant

Authorization status:

OTC monograph final

Summary of Product characteristics

CODEINE-GUAIFENESIN- CODEINE PHOSPHATE AND GUAIFENESIN SOLUTION
PREFERRED PHARMACEUTICALS 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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CODEINE-GUAIFENESIN ORAL SOLUTION
_ACTIVE INGREDIENT_
_(IN EACH TEASPOONFUL (5 ML)) _
Codeine Phosphate USP 10 mg
_PURPOSE_
Antitussive
_ACTIVE INGREDIENT_
_(IN EACH TEASPOONFUL (5 ML)) _
Guaifenesin USP 100 mg
_PURPOSE_
Expectorant
_USES_
•
•
•
•
_WARNINGS_
ASK YOUR DOCTOR BEFORE USE IF
•
•
•
•
•
temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with a
cold or
inhaled irritants
your cough to help you sleep
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus and makes cough more productive.
you have a persistent cough, this may be a sign of a serious condition
you have a persistent cough such as occurs with smoking, asthma,
chronic
bronchitis or emphysema
you have a cough that is accompanied by excessive phlegm (mucus)
you have chronic pulmonary disease or shortness of breath
giving to a child who is taking other drugs
WHEN USING THIS PRODUCT
•
•
STOP USE AND ASK A DOCTOR IF
•
IF PREGNANT OR BREAST-FEEDING
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
_DIRECTIONS_
•
Adults and children
12 years of age and over:
2 tsp (10 mL) every 4 hours, or as
directed by a doctor.
Children 6 to under
12 years of age:
1 tsp (5 mL) every 4 hours, or as directed
by a doctor.
Children under
6 years of age:
Consult a doctor.
_OTHER INFORMATION_
Store at controlled room temperature 15°-30°C (59°-86°F).
_INACTIVE INGREDIENTS_
Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol,
Purified Water,
Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.
PRINCIPAL DISPLAY PANEL
NDC 6878