Airacof

Airacof is a brand name medication included in the following groups of medications: Opium alkaloids and derivatives, Aminoalkyl ethers, Antihistamines for topical use, Adrenergic and dopaminergic agents, Sympathomimetics, Sympathomimetics excl. antiglaucoma preparations, Sympathomimetics used as decongestants, Sympathomimetics, combinations excl. corticosteroids, Sympathomimetics, plain. For more information about Airacof see its generics Codeine, Diphenhydramine, Phenylephrine

Antihistamines may cause drowsiness, dizziness, blurred vision, and otherwise impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.

Sympathomimetic amines should be used cautiously, extremely carefully and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder-neck obstruction, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

Products which contain diphenhydramine should not be used in combination with other diphenhydramine formulations; in rare cases toxic psychosis has occurred in children who received combinations of two or more diphenhydramine formulations by any route of administration including topically applied preparations.

Respiratory Depression

At high doses or in sensitive patients, codeine may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Codeine also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Infants and Children

Diphenhydramine should not be administered to premature or full-term neonates. Infants may have greater susceptibility than adults to the toxic effects of diphenhydramine. Adults who administer diphenhydramine to children should be aware that children may be at increased risk for excitability and central nervous system stimulation. Antihistamine may impair mental alertness in children.

16 fluid ounce bottles.

  NDC# 23359-019-16

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°). [see USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP/NF with child-resistance closure.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Manufactured for:
CENTURION LABS, LLC
Birmingham, AL 35243

REV. 10/09

NDC 23359-019-16

Airacof™
LIQUID

Antitussive/Decongestant/
Antihistamine

Each 5 mL (teaspoonful) contains:
Codeine phosphate	7.5 mg
(WARNING: May be habit forming)
Phenylephrine hydrochloride	7.5 mg
Diphenhydramine hydrochloride	12.5 mg

CV

Rx Only

16 fl. oz (473 mL)

CENTURION Labs, LLC
LEADING PHARMACEUTICALS

Airacof  codeine phosphate, phenylephrine hydrochloride and diphenhydramine hydrochloride liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23359-019 Route of Administration ORAL DEA Schedule CV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (Codeine) CODEINE PHOSPHATE 7.5 mg  in 5 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 7.5 mg  in 5 mL DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg  in 5 mL

Product Characteristics Color      Score      Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:23359-019-16 473 mL in 1 BOTTLE, PLASTIC

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/08/2010

Labeler - CENTURION LABS, LLC (806756461)

Revised: 01/2010   CENTURION LABS, LLC