GUAIFENESIN AC- guaifenesin and codeine phosphate syrup
Rising Pharma Holdings Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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Guaifenesin AC
| Each teaspoon (5 mL) Contains: | |
| Guaifenesin USP | 100 mg |
| Codeine Phosphate USP | 10 mg |
contains 3.5% alcohol v/v
INACTIVE INGREDIENTS
Alcohol 3.5%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol solution.
DIRECTIONS
Take every 4 hours or as directed by a doctor. Do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: Take 2 teaspoons. Children 6 to under 12 years of age: Give 1 teaspoon. Children under 6 years of age: DO NOT USE. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
WARNINGS
Do not exceed recommended dosage. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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 doctor. 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 doctor. 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.
DRUG INTERACTION PRECAUTION
Caution should be used when taking this product with 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.
TO REPORT ADVERSE DRUG EVENTS CALL: (866) 562-4597
Dispense in a tight, light-resistant container as defined in the USP.
Store at controlled room temperature 20o - 25o C (68o - 77oF). (see USP Controlled Room Temperature) DO NOT REFRIGERATE.
TAMPER-EVIDENT
Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.
Manufactured by:
Bio-Pharm, Incorporated Levittown, PA 19057
Distributed by:
Rising Pharmaceuticals, Inc. Allendale, NJ 07401
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Rising® NDC 16571-302-16
Guaifenesin AC
Cough Syrup
CV
SUGAR-FREE
GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION, USP)
COUGH SUPPRESSANT
EXPECTORANT
Each teaspoon (5 mL) Contains:Guaifenesin USP....... 100 mg
Codeine Phosphate USP..... 10 mg
contains 3.5% alcohol v/v
*Under Federal law Guaifenesin AC is available
without a prescription. Certain State laws may differ.
Manufactured by:
Bio-Pharm, Incorporated Levittown, PA 19057
Distributed by:
Rising Pharmaceuticals, Inc. Allendale, NJ 07401
TAMPER-EVIDENT
DO NOT REFRIGERATE
ONE PINT (473 mL)
| GUAIFENESIN AC
guaifenesin and codeine phosphate syrup |
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| Labeler - Rising Pharma Holdings Inc. (116880195) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Bio-Pharm, Inc. | 801652546 | MANUFACTURE(16571-302) , ANALYSIS(16571-302) , PACK(16571-302) , LABEL(16571-302) | |