FDA Label for Guaifenesin 200mg
View Indications, Usage & Precautions
Guaifenesin 200mg Product Label
The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Guaifenesin 200mg
Purpose
Expectorant
Guaifenesin 200 mg Tablets
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
Warnings
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 last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
If Pregnant Or Breast- Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
- Do not take more than 6 doses in any 24-hour period.
- This product is not intended for use in children under 12 years of age
- Adults & children 12 years and over: 1 to 2 tablets every 4 hours
- Children under 12 years: do not use
Other Information:
- Store at 15°C-30°C (59°F-86°F)
Inactive Ingredients:
Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid
Manufactured for & Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev: 02/19TCL
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 200 mg |
| 3000 | 71610-434-18 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20200619JH
Principal Display Panel - 200 Mg
NDC 71610-434 - Guaifenesin 200 mg Tablets
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