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:

Dispensing Solutions, Inc.

INN (International Name):

GUAIFENESIN

Composition:

GUAIFENESIN 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Expectorant / Cough Suppressant 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. Hypersensitivity to any of the ingredients.

Product summary:

Guaifenesin and Codeine Phosphate Oral Solution USP (red color-cherry flavor) is supplied in the following oral dosage forms: NDC 682588-8904-04 (4 fl oz bottle)

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN AND CODEINE PHOSPHATE- GUAIFENESIN AND CODEINE PHOSPHATE
SOLUTION
DISPENSING SOLUTIONS, 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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GUAIFENSIN AND CODEINE PHOSPHATE
ORAL SOLUTION USP
CV
ACTIVE INGREDIENT
Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine
Phosphate, USP 10 mg.
Under federal law, Guaifenesin and Codeine Phosphate Oral Solution USP
is available without a
prescription. Certain state laws may differ.
INACTIVE INGREDIENT
_Inactive Ingredients:_ Citric acid, edetate disodium, FD&C Blue No.
1, FD&C Red No. 40, FD&C
Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified
water, sodium benzoate, sodium
citrate, sodium saccharin, and sorbitol.
_Sodium Content:_ 5 mg/5 mL
PURPOSE
_Expectorant / Cough Suppressant_
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.
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 directe