CEPASTAT EXTRA STRENGTH- phenol lozenge

Cepastat by

Drug Labeling and Warnings

Cepastat by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (per lozenge)

Phenol 29 mg

Purpose

Oral Anesthetic

Uses

temporarily relieves

• minor sore throat pain
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Warnings

When using this product

• Do not use more than directed.

Stop use and ask a doctor if

• sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting
• sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens

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

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

Directions

• dissolve a lozenge slowly in mouth

• adults and children 12 years and older: take up to 2 lozenges every 2 hours as needed
• children 6 to under 12 years: take up to 1 lozenge every 2 hours; not more than 10 lozenges in 24 hours
• children under 6 years: ask a doctor

Other Information

Store at room temperature, below 86°F (30°C). Protect contents from humidity.

Inactive ingredients

Antifoam Emulsion, Caramel, Eucalyptus Oil, Gum Crystal, Menthol, and Sorbitol.

QUESTIONS?

Call 1-800-344-7239 or visit our website at www.insightpharma.com

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Distributed by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 18 Lozenges carton

MENTHOL EUCALYPTUS FLAVOR

CĒPASTAT®
ORAL ANESTHETIC WITH PHENOL

FAST ACTING
SORE THROAT RELIEF
EXTRA STRENGTH*

18 LOZENGES
SUGAR FREE

INGREDIENTS AND APPEARANCE

CEPASTAT  EXTRA STRENGTH
phenol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-219
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV)	Phenol	29 mg

Inactive Ingredients
Ingredient Name	Strength
Caramel (UNII: T9D99G2B1R)
Eucalyptus Oil (UNII: 2R04ONI662)
Menthol (UNII: L7T10EIP3A)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	BROWN (transparent)	Score	no score
Shape	ROUND	Size	19mm
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-219-18	18 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/07/2009

Labeler - Insight Pharmaceuticals (176792315)