Azithromycin Tablets IP 250 mg

1.
Generic Name : Azithromycin Tablets IP 250 mg
2. Brand Name : EZEE 250
3. Pharmacopoeial Status : IP
4. Strength : 250 mg
5. Dosage form : Tablets
6. Label Claim : Each film coated tablet contains:
(With special ingredients if Azithromycin IP (As dehydrate)
added in the formulation) Eq. to Azithromycin………………….250 mg
Excipients…………………………........…q.s.
7. Colours : Lake sunset yellow & titanium dioxide
8. Details of pack :
6 tablets per blister packing (1 X 6’S)
Pack size and Type of pack
9. Warning as per DCGI : SCHEDULE H PRESCRIPTION DRUG- CAUTION
Not to be sold by retail without the prescription of a Registered
Medical Practitioner.
10. Directions for use if any : NA
11. Dosage : As directed by the Physician only.
12. Storage condition and shelf : Store at a temperature not exceeding 30˚C. Protect from light &
life moisture.
13. Special warning if any : NA
14. Mfg. Lic. No. : 406/DR/mfg/2017
15. Mfg. Address : Hetero Healthcare Limited
AIIDC Industrial Growth Centre,
Changsari, Niz Sindurighopa (Village), Sila Sindurighopa
(Mouza), Kamrup (Dist) Assam-781101
16. Any other text matter for : Keep the medicine out of reach of children
printing
17. 6’s size : 76 X 35 mm
18. Aluminium Foil width : 0.025 X 160 mm
19. Base Foil : 0.25 X 164 mm white opaque PVC/PVDC Film
20. 1X6’S carton size : 80X15X40 mm
1) Brand Name: EZEE 250 mg
2) Generic Name & Strength: Azithromycin Tablets IP 250 mg
3) Formulation: Tablet
A) Description: Orange coloured caplet shaped film coated tablets.
B) Shape: Caplet Shaped.
C) Size:14.20 X 9.70 mm
D) Colour: Orange
E) Flavour: NA
F) Scoring: NA
G) Special Instructions: NA
4) Packaging
A) Packaging Material and description:

Sr. No. Name of Material Description

01 Printed aluminium foil 160 ± 1 mm / 0.025 mm Printed Aluminium foil EZEE 250 mg
(1x6’S)
02 White opaque PVC/PVDC 164 ± 1 mm 0.25 mm white opaque PVC/PVDC film EZEE
film 250 mg (1x6’S)
03 Printed inner carton Printed inner carton EZEE 250 mg 80X15X40 mm for 1x6’s
tablets
04 Printed outer carton Printed outer carton EZEE 250 mg 170X160X45 mm for 20 x 1
x 6’s tablets
05 5 ply shipper 5 Ply Shipper 490x350x440 mm for 54x20x1x6’s

06 BOPP tape Printed BOPP Tape (Hetero Healthcare Logo)

Type of Packing Blister

Primary 1 x 6’s (6 Tablets per blister)
Secondary
Inner carton 1x6’s
Outer carton 20x1x6’s (2Lx10Wx1H)
5 ply shipper 54x20x1x6’s (2Lx3Wx9H)
Special Requirements BOPP tape HETERO HEALTHCARE LOGO in “C”
shape on top and bottom to seal the 5 ply shipper.

B) Packaging Configuration:
5) Packing Procedure Flowchart:

Primary Packing

Overprint batch coding details on printed foil side with machine. Pack 6 tablets into blister having
printed foil and forming foil of white opaque PVC/PVDC film. Perform the leak test as per respective
SOP

Secondary Packing

Overprint the batch coding details on printed inner and outer carton.
Fill 1 blisters of 6 tablets into a printed inner carton and fill 20 inner carton in 1 outer carton.

Tertiary Packing

Open the shipper from one side and affix BOPP tape in “C” shape on outer side.
Fill 54 such packed printed outer cartons into 5 ply shipper with Orientation into shipper as
2LX3WX9H.
Affix the shipper label on left side top corner of shipper. Seal the shipper using printed BOPP tape
HETERO HEALTHCARE LOGO in “C” shape on top and bottom.