Albuterol Sulfate (Page 3 of 3)

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:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
GW7147
Issued: 11/2016 8-0332ACTLNC1

PRINCIPAL DISPLAY PANEL

alb syr
(click image for full-size original)

ALBUTEROL SULFATE albuterol sulfate syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1348(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
SODIUM HYDROXIDE
SODIUM BENZOATE
HYPROMELLOSES
FD&C YELLOW NO. 6 (FOOD YELLOW 3 FREE ACID)
PROPYLENE GLYCOL
CITRIC ACID MONOHYDRATE
WATER
SODIUM CITRATE
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1348-1 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074454 01/01/2018
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-1348), relabel (67296-1348)

Revised: 01/2020 RedPharm Drug, Inc.

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