Ryvent

You should not use carbinoxamine if you are allergic to it.

Do not use carbinoxamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Do not breast-feed a baby while taking carbinoxamine. This medicine may cause side effects in the nursing baby.

Do not give this medicine to a child younger than 2 years old. Death can occur from the misuse of cough and cold medicines in very young children. Talk with your doctor about other FDA-approved products available for use in young children with cold or allergy symptoms. Always ask a doctor before giving a cough or cold medicine to a child.

You should not use antihistamine medication to make a child sleepy.

To make sure carbinoxamine is safe for you, tell your doctor if you have:

• narrow-angle glaucoma;

• heart disease or high blood pressure;

• a stomach ulcer;

• a blockage in your digestive tract (stomach or intestines);

• a bladder obstruction or other urination problems;

• an enlarged prostate;

• asthma; or

• overactive thyroid.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Carbinoxamine maleate is a histamine-H1 receptor blocking agent.

Each tablet contains 6 mg carbinoxamine maleate and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

Carbinoxamine maleate is freely soluble in water. Its structure is:

2-[(4-chlorophenyl)-2-pyridinylmethoxy]-N, N-dimethylethanamine (Z)-2-butenedioate (1:1)

C16H19CIN2O·C4H4O4

MW= 406.86

Deaths have been reported in children less than 2 years of age who were taking antihistamines, including carbinoxamine-containing drug products, therefore, carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).

Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction.

The most frequent adverse reactions are underlined:

Body as a whole: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat

Cardiovascular: Hypotension, headache, palpitations, tachycardia, extrasystoles

Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis

Central nervous system:Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions

Gastrointestinal:Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation

Urogenital: Urinary frequency, difficult urination, urinary retention, early menses

Respiratory:Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness

Call your doctor for medical advice about side effects. Report side effects to 1-844-700-5011.

Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).

Carbinoxamine maleate should be taken on an empty stomach with water.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. The drug is well tolerated in adults in doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily.

Clinical experience suggests the following dosage schedule:

Usual Adult Dosage: 1 tablet (6 mg) 3 to 4 times daily

RyventTM (carbinoxamine maleate tablets USP, 6 mg) is supplied as a white, round tablet, debossed “404” on one side and “ADG” on the other side, in bottles of 100 tablets, NDC 15370-130-10 and bottles of 2 tablets as physician samples, NDC 15370-130-02.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the official compendium.

Rx only

Manufactured for:

Carwin Pharmaceutical Associates, LLC

Hazlet, NJ 07730

www.carwinpharma.com

Code 1159B00

Rev. 09/16