Label: GUAIFENESIN AND CODEINE PHOSPHATE solution
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Contains inactivated NDC Code(s)
NDC Code(s): 68258-8904-4 - Packager: Dispensing Solutions, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0121-0775
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 18, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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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
- CONTRAINDICATIONS
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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 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.
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).
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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 products used alone. (See WARNINGS)
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DOSAGE and ADMINISTRATION
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
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
NDC 68258-8904-04
Guaifenesin and Codeine
Phosphate Oral Solution USP
CV100 mg/10 mg per 5 mL
Expectorant / Cough Suppressant
Alcohol Free / Sugar Free
Each teaspoonful (5 mL) contains:
Guaifenesin, USP 100 mg
Codeine Phosphate, USP 10 mgDispense in a tight, light-resistant
container with a child-resistant closure.DO NOT ACCEPT IF IMPRINTED SEAL
AROUND CAP IS BROKEN OR MISSING.4 fl oz (118 mL)
pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605NDC 68258-8904-04
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INGREDIENTS AND APPEARANCE
GUAIFENESIN AND CODEINE PHOSPHATE
guaifenesin and codeine phosphate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68258-8904(NDC:0121-0775) Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) edetate disodium (UNII: 7FLD91C86K) FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Red No. 40 (UNII: WZB9127XOA) FD&C Yellow No. 6 (UNII: H77VEI93A8) glycerin (UNII: PDC6A3C0OX) menthol (UNII: L7T10EIP3A) propylene glycol (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sodium citrate (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) sorbitol (UNII: 506T60A25R) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68258-8904-4 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/01/2006 Labeler - Dispensing Solutions, Inc. (066070785) Registrant - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 relabel(68258-8904) , repack(68258-8904)