General Labelling Requirements

The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed:

1. Drug name: the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any.

2. Net content: weight, volume, in metric system or units.

3. Content of Active ingredients:

• Oral liquids: Contents per single dose, i.e. 5 ml or multiple thereof. If dose is below 5 ml, then per ml.
• Liquid parenterals: Contents per ml or in percentage or per dose.
• Solid parenterals: Contents per mg or per gm or in terms of units.
• Tablets, capsules and pills: Contents per tablet, capsule, pill.
• For other preparations: Contents in terms of percentage by w/w or w/v or units per gm or ml.

4. Name and address of manufacturer.

5. Manufacturing license number: Mfg. Lic. No. or ML No.

6. Batch number: Batch No. or Lot No.

7. Date of manufacturing: Mfg. Date.

8. Date of expiry: Exp. Date

9. Free samples to medical profession: "Physician's Sample - Not To Be Sold".

10. Alcoholic preparations: If alcoholic content exceeds 3% by volume, percentage of alcohol must be mentioned on the lable.

11. Information of handling, use, distribution, storage etc.

12. Maximum Retail Price: M.R.P.

13. Hair dyes containing coal tar colours: 

• on inner and outer label both, in English and local languages: "Caution: The product contains ingredients which may cause skin irritation in certain cases and so preliminary test according to the accompanying directions shall first be made. This product shall not be used for dyeing the eyelashes or eyebrows as such if used, may cause blindness'".

14. Toothpaste containing Fluoride: Fluoride content in ppm (NMT 1000 ppm); Date of expiry.

Special Labeling Requirement 

Schedule C1	Date of Manufacture, Expire, Import license number.
Schedule G	“It is dangerous to take this preparation except under medical supervision.”
Schedule H	Symbol RX is required on the left corner of label; (“To be sold by retail on the prescription of a RMP only”) Symbol NRX is required for Narcotic Drugs on the Top left corner with red ink. (“To be sold by retail on the prescription of a RMP only”)
Schedule X	Symbol XRX on the left corner of label; (“To be sold by retail on the prescription of a RMP only”)
Preparations for External Use	FOR EXTERNAL USE ONLY
Pharmacopoeia Preparation	‘I.P.’ , ‘U.S.P.’ etc
Patents and Proprietary Medicines	Quantities of API
Ophthalmic Preparations	Schedule FF (i)               “Use the solution within 1 month after opening.” (ii)              Concentration of Preservative Used (iii)            “Not for injection” (iv)            Storage Instructions (v)              Warning: “If irritation increases, discontinue the use and consult physician.” (vi)            “Do not touch the dropper tip to any surface since this may contaminate the solution.
Medicines for Animals	“NOT FOR HUMAN USE, FOR ANIMAL TREATMENT ONLY”