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| Product NDC Code | 76281-507 | ||||
|---|---|---|---|---|---|
| Drug Name | Tussin expectorant |
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| Type | Brand | ||||
| Pharm Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 310604 | ||||
| Application Number | M012 | ||||
| Labeler Name | AptaPharma, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each 5 mL teaspoon) 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 ■ do not take more than 6 doses in any 24-hour period. Age Dose Adults and children 12 years and over 2-4 teaspoonfuls every 4 hours Children under 12 years do not use
| Children under 12 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate
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 ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose
Information about the drug product’s indications for use.Purpose Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Tussin Expectorant GUAIFENESIN GUAIFENESIN GUAIFENESIN CARAMEL ANHYDROUS CITRIC ACID DEXTROSE FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP MENTHOL WATER SACCHARIN SODIUM SODIUM BENZOATE
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 AP SAFE NDC 76281-507-24 *COMPARE TO THE ACTIVE INGREDIENT IN ROBITUSSIN ® MUCUS+CHEST CONGESTION. Adult Tussin Expectorant Guaifenesin Oral Solution, USP Non-Drowsy • Relieves Chest Congestion • Loosens Mucus • For ages 12 & Over 4 FL OZ (118 mL) DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING AP-BX-04 *This product is not manutactured or distributed by Pfizer, the distributor of Robitussin ® Mucus plus Chest Congestion. Manufactured by: AplaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 Carton Bottle res 507-24 4 OZ Box 507-24 4 OZ Btl
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. In case of overdose, get medicai help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each 5 mL contains: sodium 3 mg ■ store between 20-2S o C (68-77°F) ■ do not refrigerate ■ dosing cup provided ■ Keep carton for full directions for use
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions ? Call weekdays from 9:30AM to 4:30 PM EST at 1-877-798-5944
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ do not use more than directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast·feeding , ask ahealth professional before use.
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 Ask a doctor before use if you have ■ cough that occurs with too much phlegm (mucus) ■ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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