FDA Label for Fedrin
View Indications, Usage & Precautions
Fedrin Product Label
The following document was submitted to the FDA by the labeler of this product Afassco Inc.. 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.
Otc - Active Ingredient
Active Ingredients (In Each Tablet)
Acetaminophen 500 mg, Phenylephrine HCl 5 mg
Otc - Purpose
Pain reliever/fever reducer, Nasal decongestant
Indications & Usage
Uses:
For temporary relief of nasal congestion associated with sinusitis.
Temporarily relieves headache and sinus pain.
Warnings
Warnings:
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, if you take with other drugs containing acetaminophen (prescription or nonprescription), or if you have 3 or more alcoholic drinks every day while using this product.
Otc - Ask Doctor
Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that occurs with too much phlegm (mucus), chronic cough that lasts such as occurs with smoking, asthma, or emphysema or chronic bronchitis.
Otc - Stop Use
Stop use and ask a doctor if: you get nervous, dizzy or sleepless, cough lasts more than 7 days, comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions: Do not use more than directed.
Adults and children: (12 years and older) Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours, or as directed by doctor.
Children: (under 12 years)
Do use unless directed by a doctor.
Inactive Ingredient
SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION
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