Fedrin

Manufacturer
Afassco Inc.
Effective date
2019-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:02:04

Label at a glance#

ProductFedrin
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (In Each Tablet)

Acetaminophen 500 mg, Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Pain reliever/fever reducer, Nasal decongestant

INDICATIONS & USAGE SECTION

Uses:

For temporary relief of nasal congestion associated with sinusitis.

Temporarily relieves headache and sinus pain.

WARNINGS SECTION

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 SECTION

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 SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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 SECTION

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 SECTION

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AfascoFedrin12-16AfascoFedrin12-16

res

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51532-0140-22023-01-30C16284748780-1f386c64a-33dc-0266-e053-dadaa90a7c1aDrug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51532-014051532-0140-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b76dd159-ad39-48cb-889c-2a97b1f9d52d05d80f93-020c-48a5-b72f-4a91908949b82019-12-18WarningsExact identifier
spl id: b76dd159-ad39-48cb-889c-2a97b1f9d52d
spl set id: 05d80f93-020c-48a5-b72f-4a91908949b8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.