SPL v1
SPL
SPL Set ID 25d0bfab-3dd1-c34b-e063-6294a90ab2d1
Route
ORAL
Published
Effective Date 2024-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Flurbiprofen (8.75 mg)
Inactive Ingredients
Mannitol Levomenthol

Identifiers & Packaging

Pill Appearance
Imprint: PHARMKN Shape: round Color: pink Size: 19 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-11-01
Description

flurbiprofen

Medication Information

Warnings and Precautions

please see attached Drug Facts

Indications and Usage

please see attached Drug Facts

Dosage and Administration

oral use only

Description

flurbiprofen

Section 50565-1

Keep out of reach of children

Section 51727-6

d-mannitil, l-menthol, L-menthol

Section 51945-4

Section 55105-1

for swelling and sore throat symptoms, temporarily reduces feber, relieves swelling and sore throat for tonsillitis/peritonsillitis

Section 55106-9

flurbiprofen

Structured Label Content

Indications and Usage (34067-9)

please see attached Drug Facts

Dosage and Administration (34068-7)

oral use only

Warnings and Precautions (34071-1)

please see attached Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

d-mannitil, l-menthol, L-menthol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for swelling and sore throat symptoms, temporarily reduces feber, relieves swelling and sore throat for tonsillitis/peritonsillitis

Section 55106-9 (55106-9)

flurbiprofen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:09.684349 · Updated: 2026-03-14T23:04:39.787858