Skip to main content

Fedrin

Medically reviewed by Drugs.com. Last updated on Dec 18, 2019.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 5001, PHENYLEPHRINE HYDROCHLORIDE 51
Labeler: Afassco Inc.
NDC Code: 51532-0140

Drug Facts

Active Ingredients (In Each Tablet)

Acetaminophen 500 mg, Phenylephrine HCl 5 mg

Pain reliever/fever reducer, Nasal decongestant

Uses:

For temporary relief of nasal congestion associated with sinusitis.

Temporarily relieves headache and sinus pain.

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.

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.

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.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

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.

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.

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

res

FEDRIN 
acetaminophen, phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-0140
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE 
FD&C BLUE NO. 1 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize12mm
FlavorImprint CodeFR33
Contains    
Packaging
#Item CodePackage Description
1NDC:51532-0140-22 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/25/2016
Labeler - Afassco Inc. (609982723)

 
Afassco Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.