FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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.
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.
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.
The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
AIRACOF™ is an antihistamine, antitussive and decongestant indicated for the symptomatic relief of cough, runny nose, nasal and eustachian tube congestion associated with the common cold, allergy, sinusitis and acute upper respiratory tract infections.
History
There is currently no drug history available for this drug.
Other Information
A Strawberry-Flavored, clear, alcohol-free, sugar-free, dye-free, liquid for oral administration.
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 |
The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The chemical name is Morphinan-6-ol,7,8-didehydroxy-4,5-eposy-3methoxy-17-methyl-, (5α,6α)-, phosphate (1:1) (salt), hemihydrate.
Phenylephrine hydrochloride is a mydriatic and a decongestant and occurs as bitter crystals. The chemical name is: (-)-m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride.
Diphenhydramine hydrochloride is an antihistaminic. The chemical name is 2-(diphenylmethoxy)-N, N-dimethylethylamine hydrochloride.
Inactive Ingredients: Sodium benzoate, Citric acid, Saccharin sodium, Propylene glycol, Sorbitol, Flavor and Purified water.
Sources
Airacof Manufacturers
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Centurion Labs, Llc
Airacof | Centurion Labs, Llc
Individuals 12 years of age and over2 teaspoonfuls (10 mL) every 4 hours, not to exceed 8 teaspoonfuls in 24 hours.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSOIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
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