Label claim of a pharmaceutical product means the statement on a drug product about the amount of API, form of API and its effects.
Or
The amount of Active ingredient(s) (API) (usually in mg or percentage %) added in one unit (Tablet, Capsule, Vial etc.).
For Example,
Panadol Extra tablet contains Paracetamol 665 mg and Caffein 65 mg.
Here, 665 mg is label claim for Paracetamol & 65 mg is label claim for Caffeine.
Label Claim Calculation
The Label Claim method is an alternate method that is used by some pharmaceutical companies. In this method, the overage is a percentage of the label claim amount. It is also called percent label claim calculation.
For example,
If the label claim amount is 500 mg and the overage is 5%, the per-serving method calculation looks like this: 500 mg label claim
500 mg label claim × 1.05 = 525 mg per serving
or
500 mg label claim / 0.95 = 526.32 mg per serving
Label claim is affixed to the container or packaging of the drug, any separate package inserts, product monographs, prescribing information, fact sheets, consumer information/patient medication information (i.e., patient leaflets), patient diaries, or other material containing information specific to the drug product.
Method of Declaring Quantities of Active Ingredients
- Tablets, capsules, suppositories and other discrete dosage forms: gram (g) or milligram (mg) per dosage form.
- Powders for oral use: gram (g) or milligram (mg) per gram, and per specific dosage unit (for example, level teaspoonful).
- Liquids for parenteral use: milligram (mg) per milliliter (ml), or % weight per volume (w/v)
- Creams, lotions, ointments: milligram (mg) per gram (g)(= mg/g or % w/w), or milligram per milliliter (= mg/ml or %w/v)