SUNMARK 12 HOUR ALLERGY RELIEF

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Clemastine fumarate, USP 1.34 mg (equivalent to 1 mg clemastine)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily reduces these symptoms of the common cold, hay fever, and other respiratory allergies:

1. runny nose
2. itchy, watery eyes
3. sneezing
4. itching of the nose or throat

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

1. a breathing problem such as emphysema or chronic bronchitis
2. glaucoma
3. trouble urinating due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

1. avoid alcoholic drinks
2. drowsiness may occur
3. alcohol, sedatives, and tranquilizers may increase drowsiness
4. be careful when driving a motor vehicle or operating machinery
5. excitability may occur, especially in children

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

1. adults and children 12 years of age and over: take 1 tablet every 12 hours; not more than 2 tablets in 24 hours unless directed by a doctor
2. children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

1. sodium free
2. store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, lactose monohydrate, povidone, pregelatinized starch, starch, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Tavist® Allergy active ingredient

12 Hour Allergy Relief

Clemastine Fumarate Tablets, USP 1.34 mg

Antihistamine

Relieves: Runny Nose, Sneezing

Itchy, Watery Eyes, Itchy Throat

Allergy

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

• SUNMARK 12 HOUR ALLERGY RELIEF
• Clemastine fumarate
• CLEMASTINE
• SILICON DIOXIDE
• LACTOSE MONOHYDRATE
• POVIDONE
• STARCH, CORN
• STEARIC ACID

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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.

Reported adverse events (FAERS/openFDA)#

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