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| Product NDC Code | 50383-087 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Guaiatussin ac sugar free |
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| Type | Brand | ||||||||||
| Pharm Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | LIQUID | ||||||||||
| RxCUI drug identifier | 995868 | ||||||||||
| Application Number | part341 | ||||||||||
| Labeler Name | Akorn Operating Company LLC | ||||||||||
| Packages |
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| Check if available Online |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each 5 mL teaspoonful) Codeine Phosphate, USP 10 mg Guaifenesin, USP 100 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • take every 4 hours • do not exceed 6 doses in 24 hours • 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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients alcohol 3.5% v/v, artificial cherry flavor, caramel, citric acid, FD&C red # 40, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Purpose
Information about the drug product’s indications for use.Purposes Cough Suppressant Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Guaiatussin AC Sugar Free guaifenesin and codeine phosphate CODEINE PHOSPHATE CODEINE ANHYDROUS GUAIFENESIN GUAIFENESIN ALCOHOL CARAMEL ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL 4000 WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL artificial cherry flavor
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Principal Display Panel AKORN NDC 50383-087-16 Guaiatussin AC Sugar-Free • Expectorant • Cough Suppresant Each teaspoonful (5 mL) contains Guaifenesin ……………. 100 mg Codeine Phosphate…….. 10 mg Alcohol………………….... 3.5% v/v Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 16 fl oz (473 mL) Container Label 16 oz
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information • each (5 mL) teaspoon contains: 1 mg sodium • Tamper evident: Do not use if seal under cap is broken or missing. • Keep container closed and away from heat. • Store at room temperature 15°- 30°C (59°-86°F)
Questions or comments? Call 1-800-932-5676 , Mon.-Thurs 9:00 am thru 4:30 pm EST, Fri. 9:00 am thru 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children
Keep Out of Reach of Children In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. • Use of codeine-containing preparations is not recommended for children under 2 years of age
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. • may cause or aggravate constipation If pregnant or breast-feeding ask a health professional before use. Keep Out of Reach of Children In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. • Use of codeine-containing preparations is not recommended for children under 2 years of age
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API