Albuterol Sulfate: Package Insert and Label Information (Page 2 of 2)

Pediatric Use

Safety and effectiveness in children below 2 years of age have not been established.

ADVERSE REACTIONS

In clinical trials, the most frequent adverse reactions to albuterol sulfate syrup in adults and older children were:

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In clinical trials, the following adverse reactions to albuterol sulfate syrup were noted more frequently in young children 2 to 6 years of age than in older children and adults:

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Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate syrup.
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.
The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol sulfate syrup. In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.
T o report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate syrup. Treatment consists of discontinuation of albuterol sulfate syrup together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol sulfate syrup.
The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 240 times the maximum recommended daily oral dose for adults and children on a mg/m 2 basis). In mature rats the subcutaneous (sc) median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 110 times the maximum recommended daily oral dose for adults and children on a mg/m 2 basis). In small young rats the oral median lethal dose is approximately 2000 mg/kg (approximately 480 times the maximum recommended daily oral dose for adults and children on a mg/m 2 basis).

DOSAGE AND ADMINISTRATION

The following dosages of Albuterol Sulfate Syrup are expressed in terms of albuterol base.

Usual Dosage
Adults and Children Over 14 Years of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.

Children Over 6 Years to 14 Years of Age: The usual starting dosage for children over 6 years to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.

Children 2 to 5 Years of Age: Dosing in children 2 to 5 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.

Dosage Adjustment
Adults and Children Over 14 Years of Age: For adults and children over 14 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.

Children Over 6 Years to 14 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day: For children over 6 years to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).

Children 2 to 5 Years of Age Who Do Not Respond Satisfactorily to the Initial Dosage: For children from 2 to 5 years of age who do not respond satisfactorily to the initial starting dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.

Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.

HOW SUPPLIED

Albuterol Sulfate Syrup, a clear, yellow liquid with a strawberry flavor, contains 2 mg of albuterol (present as the sulfate) per 5 mL in bottles of 4 fluid ounces (NDC 0472-0825-04) and 16 fluid ounces (one pint) (NDC 0472-0825-16).


Store at controlled room temperature 15°-30°C (59°-86°F).
Dispense in a tight, light-resistant container as defined in the USP.
Manufactured by:
Cosette Pharmaceuticals, Inc.
Lincolnton, NC 28092

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
VC7466

Revised: 11/2020 8-0332ACTLNC2

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PRINCIPAL DISPLAY PANEL

NDC 0472-0825-16

Albuterol Sulfate Syrup 2 mg* per 5 mL

One Pint (473 mL)

Rx Only

Cosette Pharmaceuticals, Inc.

carton 5ml
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ALBUTEROL SULFATE albuterol sulfate syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-0825
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 2 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE
SODIUM HYDROXIDE
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0472-0825-16 473 mL in 1 BOTTLE None
2 NDC:0472-0825-04 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074454 02/19/2016
Labeler — Actavis Pharma, Inc. (119723554)
Registrant — Cosette Pharmaceuticals, Inc. (116918230)
Establishment
Name Address ID/FEI Operations
Cosette Pharmaceuticals NC Laboratories, LLC 079419931 analysis (0472-0825), label (0472-0825), manufacture (0472-0825), pack (0472-0825)

Revised: 11/2021 Actavis Pharma, Inc.

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