Guaifenesin And Codeine Phosphate Solution label

Guaifenesin And Codeine Phosphate Solution

Guaifenesin And Codeine Phosphate Solution Recall

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Side Effects & Adverse Reactions

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 children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a physician. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg.

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

Under federal law, Guaifenesin and Codeine Phosphate Oral Solution USP is available without a prescription. Certain state laws may differ.

Guaifenesin And Codeine Phosphate Solution Manufacturers

  • Guaifenesin And Codeine Phosphate Solution | A-s Medication Solutions Llc
    No Recall

    Guaifenesin And Codeine Phosphate Solution | A-s Medication Solutions Llc

    Guaifenesin And Codeine Phosphate Solution | A-s Medication Solutions Llc

    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.

  • Pharmaceutical Associates, Inc.
    Guaifenesin And Codeine Phosphate Solution | Pharmaceutical Associates, Inc.
    No Recall

    Guaifenesin And Codeine Phosphate Solution | Pharmaceutical Associates, Inc.

    Guaifenesin And Codeine Phosphate Solution | Pharmaceutical Associates, Inc.

    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.

  • Dispensing Solutions, Inc.
    Guaifenesin And Codeine Phosphate Solution | Dispensing Solutions, Inc.
    No Recall

    Guaifenesin And Codeine Phosphate Solution | Dispensing Solutions, Inc.

    Guaifenesin And Codeine Phosphate Solution | Dispensing Solutions, Inc.

    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.

  • Guaifenesin And Codeine Phosphate Solution | Bausch & Lomb Incorporated
    No Recall

    Guaifenesin And Codeine Phosphate Solution | Bausch & Lomb Incorporated

    Guaifenesin And Codeine Phosphate Solution | Bausch & Lomb Incorporated

    In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.

  • Apotheca, Inc
    Guaifenesin And Codeine Phosphate Solution | Apotheca, Inc
    No Recall

    Guaifenesin And Codeine Phosphate Solution | Apotheca, Inc

    Guaifenesin And Codeine Phosphate Solution | Apotheca, Inc

    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

  • Lake Erie Medical Dba Quality Care Products Llc
    Guaifenesin And Codeine Phosphate Solution | Lake Erie Medical Dba Quality Care Products Llc
    No Recall

    Guaifenesin And Codeine Phosphate Solution | Lake Erie Medical Dba Quality Care Products Llc

    Guaifenesin And Codeine Phosphate Solution | Lake Erie Medical Dba Quality Care Products Llc

    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.

  • Guaifenesin And Codeine Phosphate Solution | A-s Medication Solutions Llc
    No Recall

    Guaifenesin And Codeine Phosphate Solution | A-s Medication Solutions Llc

    Guaifenesin And Codeine Phosphate Solution | A-s Medication Solutions Llc

    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.

  • Proficient Rx Lp
    Guaifenesin And Codeine Phosphate Solution | Proficient Rx Lp
    No Recall

    Guaifenesin And Codeine Phosphate Solution | Proficient Rx Lp

    Guaifenesin And Codeine Phosphate Solution | Proficient Rx Lp

    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.

  • Guaifenesin And Codeine Phosphate Solution | Directrx
    No Recall

    Guaifenesin And Codeine Phosphate Solution | Directrx

    Guaifenesin And Codeine Phosphate Solution | Directrx

    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.