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| Product NDC Code | 51660-567 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Guaifenesin |
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| Type | Generic | ||||||||
| 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 | TABLET, EXTENDED RELEASE | ||||||||
| RxCUI drug identifier | 310621, 636522 |
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| Application Number | ANDA209254 | ||||||||
| Labeler Name | Ohm Laboratories, Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each extended-release tablet) Guaifenesin, USP
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 crush, chew or break extended-release tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children over 12 years of age and over: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours. • children under 12 years of age: do not use. Other information • store between 20-25°C (68-77°F) • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING. Keep the carton. It contains important information. See end panel for expiration date. †Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients colloidal silicon dioxide, FD&C blue # 2, aluminum lake, hypromellose, magnesium stearate, povidone. Questions call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.
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 bronchial 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.Guaifenesin Guaifenesin GUAIFENESIN GUAIFENESIN SILICON DIOXIDE FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE, UNSPECIFIED blue/white mottled RH;98 Guaifenesin Guaifenesin GUAIFENESIN GUAIFENESIN SILICON DIOXIDE FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE, UNSPECIFIED blue/white mottled RH;99
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 600 mg 20's
Package/Label Principal Display Panel 600mg 40's
Principal Display Panel 1200mg 14 count
Principal Display Panel 1200mg 28 count
Principal Display Panel 1200 mg 56 count
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 medical help or contact a Poison Control Center right away (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.
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 • for children under 12 years of age Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) 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 serious illness. If pregnant or breast-feeding, ask a health professional before use.
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