Label: GUAIATUSSIN AC SUGAR FREE- guaifenesin and codeine phosphate liquid
- NDC Code(s): 55154-9627-5
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 50383-087
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
Drug Label Information
Updated November 15, 2023
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- Active ingredients (in each 5 mL teaspoonful)
- Purposes
- Keep Out of Reach of Children
- Uses
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Warnings
Do not use
- •
- in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor
Ask a doctor before use if you have
- •
- a cough with too much phlegm (mucus)
- •
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
taking 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.
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Directions
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- take every 4 hours
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- do not exceed 6 doses in 24 hours
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- a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
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- giving a higher dose than recommended by a doctor can result in serious side effects for a child
adults and children 12 years and over
2 teaspoonfuls
children 6 to under 12 years of age
1 teaspoonfuls
children under 6 years of age
Consult a doctor
- Other information
- Inactive Ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
GUAIATUSSIN AC SUGAR FREE
guaifenesin and codeine phosphate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-9627(NDC:50383-087) Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CARAMEL (UNII: T9D99G2B1R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor CHERRY (artificial cherry flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-9627-5 5 in 1 BAG 09/08/2010 1 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/08/2010 Labeler - Cardinal Health 107, LLC (118546603)