Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 5

LABELLING

Page 1 of 7

October 2021

Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 5

October 2021

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Bottle1. Name of the medicinal product[TB302 trade name]* Isoniazid/Rifampicin 50mg/75mg Dispersible Tablets
2. Statement of active substance
Each tablet contains 50 mg isoniazid and 75 mg rifampicin.
3. List of excipientsContains aspartame
See patient information leaflet for further information.
4. Pharmaceutical form and contents
Dispersible tablets
100 tablets
5. Method and route of administration
Oral use.
Read the patient information leaflet before use.
6. Special warning that the medicinal product must be stored out of the reach andsight of children
Keep this medicine out of the sight and reach of children.
7. Other special warning(s), if necessary
8. Expiry date
EXP {MM/YYYY}
Date opened {DD/MM/YYYY}
9. Special storage conditions
Do not store above 25°C. Store in dry place. Protect from light.
Once opened, use within 120 days.
10. Special precautions for disposal of unused medicinal products or waste materials
derived from such medicinal products, if appropriate
11. Name and address of the supplier
Macleods Pharmaceuticals Limited
304, Atlanta Arcade
Marol Church road
Andheri (East)
Mumbai - 400 059
India
12. WHO Reference Number (Prequalification Programme)
TB302
13. Manufacturer’s batch number<Batch> <Lot> {number}*

Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s responsibility.
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Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 5

14. (Advice on) General classification for supply
Medicinal product subject to medical prescription.
15. Instructions on use

Page 3 of 7

October 2021

Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 5

October 2021

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Strip pack carton
1. Name of the medicinal product[TB302 trade name] Isoniazid/Rifampicin 50mg/75mg Dispersible Tablets
2. Statement of active substance
Each tablet contains 50 mg isoniazid and 75 mg rifampicin.
3. List of excipientsContains aspartame
See patient information leaflet for further information.
4. Pharmaceutical form and contents
Dispersible tablets
10 x 10 tablets
5. Method and route of administration
Oral use.
Read the patient information leaflet before use.
6. Special warning that the medicinal product must be stored out of the reach andsight of children
Keep this medicine out of the sight and reach of children.
7. Other special warning(s), if necessary
8. Expiry date
EXP {MM/YYYY}
9. Special storage conditions
Do not store above 25°C, store in dry place, protect from light.
10. Special precautions for disposal of unused medicinal products or waste materials
derived from such medicinal products, if appropriate
11. Name and address of the supplier
Macleods Pharmaceuticals Limited
304, Atlanta Arcade
Marol Church road
Andheri (East)
Mumbai - 400 059
India
12. WHO Reference Number (Prequalification Programme)
TB302
13. Manufacturer’s batch number<Batch> <Lot> {number}
14. (Advice on) General classification for supply
Medicinal product subject to medical prescription.

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Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 5

15. Instructions on use

Page 5 of 7

October 2021

Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 5

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIP
Alu/Alu strip
1. Name of the medicinal product[TB302 trade name] Isoniazid/Rifampicin 50mg/75mg Dispersible Tablets
2. Name of the supplier
Macleods Pharmaceuticals Limited
3. Expiry date
4. Manufacturer’s batch number<Batch> <Lot>{number}
5. Other

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October 2021

Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 5

October 2021

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGINGUNITS{Nature/type}
1. Name of the medicinal product and route(s) of administration[<PQ number> trade name] {name} {strength} {pharmaceutical form}{Active substance(s)}{Route(s) of administration}
2. Method of administration

3. Expiry date

4. Manufacturer’s batch number<Batch> <Lot> {number}
5. Contents by weight, by volume, or by unit

6. Other

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