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:

Apotheca, Inc

INN (International Name):

Guaifenesin

Composition:

Guaifenesin 100 mg in 5 mL

Administration route:

oral

Prescription type:

OTC DRUG

Therapeutic indications:

INDICATIONS Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. CONTRAINDICATIONS Hypersensitivity to any of the ingredients.

Product summary:

Take orally as stated below or use as directed by a physician. Adults and children 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours, not to exceed 12 teaspoonfuls in a 24-hour period; Children 6 to under 12 years: 5 mL (1 teaspoonful) every 4 hours, not to exceed 6 teaspoonfuls in a 24-hour period; Children under 6 years: Consult a physician. 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 physician could result in serious side effects for a child. Use of codeine-containing preparations is not recommended for children under 2 years of age. Do not exceed recommended dosage. STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).  Protect from light. HOW SUPPLIED Guaifenesin and Codeine Phosphate Oral Solution USP (red color-cherry flavor) is supplied in the following oral dosage forms:  NDC 12634-969-04 (4 fl oz  (120mL) bottle Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605 Distrubited by: Apotheca, Inc. Phoenix, AZ 85006

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN AND CODEINE PHOSPHATE- GUAIFENESIN AND CODEINE PHOSPHATE
SOLUTION
APOTHECA, 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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GUAIFENESIN AND CODEINE PHOSPHATE CV
ACTIVE INGREDIENT
Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine
Phosphate, USP 10 mg.
ABOUT
ACTIONS
This product combines the expectorant, guaifenesin, with the cough
suppressant, codeine. Guaifenesin
enhances the output of lower respiratory tract fluid. The enhanced
flow of less viscid secretions
promotes and facilitates the removal of mucus. Codeine is a centrally
acting agent which elevates the
threshold for cough.
As a result, dry, unproductive coughs become more productive and less
frequent.
INDICATIONS
Temporarily controls cough due to minor throat and bronchial
irritation as may occur with the common
cold or inhaled irritants. Helps loosen phlegm (mucus) and thin
bronchial secretions to make coughs
more productive.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
_KEEP OUT OF REACH OF CHILDREN_
In case of accidental overdose, seek professional assistance or
contact a Poison Control Center
immediately.
INDICATIONS & USAGE
INDICATIONS
Temporarily controls cough due to minor throat and bronchial
irritation as may occur with the common
cold or inhaled irritants. Helps loosen phlegm (mucus) and thin
bronchial secretions to make coughs
more productive.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
WARNINGS
A persistent cough may be a sign of a serious condition. If cough
persists for more than 1 week, tends
to recur, or is accompanied by fever, rash or persistent headache,
consult a physician. Do not take this
product for persistent or chronic cough such as occurs with smoking,
asthma, chronic bronchitis,
emphysema, or if cough is accompanied by excessive phlegm (mucus)
unless directed by a physician.
Adults and child