Azithromycin Dihydrate (Page 6 of 6)

15 REFERENCES

1. Griffith DE, Aksamit T, Brown-Elliot BA, et al. An official ATS/IDSA statement: Diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007; 175:367-416.

16 HOW SUPPLIED/STORAGE AND HANDLING

Azithromycin Tablets USP, 600 mg (debossed “OE” on one side and “600” on the other side) are supplied as white, oval-shaped, film coated tablets containing azithromycin dihydrate equivalent to 600 mg azithromycin. These are packaged in bottles of 30 tablets:

Bottles of 30 tablets with child-resistant closure

NDC 51224-222-30

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in tight containers (USP).

17 PATIENT COUNSELING INFORMATION

Azithromycin tablets may be taken with or without food. However, increased tolerability has been observed when tablets are taken with food.

Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.

The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.

Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant.

Patients should be counseled that antibacterial drugs, including azithromycin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When azithromycin is prescribed to treat bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by azithromycin or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibacterial which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible.

Manufactured by:
CSPC Ouyi Pharmaceutical Co., Ltd.
Shijiazhuang, Hebei, China, 052160

Manufactured for:
TAGI Pharma, Inc.
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL — 600 mg Tablet Bottle Label

NDC 51224-222-30

Azithromycin
Tablets, USP

600 mg

CSPC^®

tagi PHARMA
That’s A Good Idea.

30 TabletsRx only

AZITHROMYCIN DIHYDRATE azithromycin dihydrate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51224-222 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Azithromycin dihydrate (Azithromycin anhydrous) Azithromycin anhydrous 600 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE POLYETHYLENE GLYCOL 3350 MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape OVAL Size 19mm Flavor Imprint Code OE;600 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51224-222-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207566 07/01/2019

Labeler — TAGI Pharma, Inc. (963322560)

Establishment
Name	Address	ID/FEI	Operations
CSPC Ouyi Pharmaceutical Co., Ltd		421303775	MANUFACTURE (51224-222), PACK (51224-222), LABEL (51224-222), ANALYSIS (51224-222)

Revised: 11/2021 TAGI Pharma, Inc.