Daily Intakes for Colorants

Iron Oxides are commonly used pharmaceutical grade colorants.

The World Health Organization (WHO), the US Code of Federal Regulations (CFR), and the Japanese Pharmaceutical Excipients Directory (JPED) have set guidelines on injestion of Iron Oxide and Elemental Iron.

For each size DBcaps capsule, the tables below indicate the maximum number of DBcaps capsules that are within these limits set by global regulatory agencies:

WHO	—	0.5 mg /day / kg of iron oxide (calculations based on standard human weight of 60 kg)
CFR	—	5 mg /day of elemental iron
JPED	—	95.4 md/day of red iron oxide; 5.67 mg/day of yellow iron oxide; 1.539 mg/day of black iron oxide

SIZE AAA

Color	Maximum Number of Capsules/Day to Meet Regulatory Limits
	WHO	CFR	JPED
Swedish Orange Opaque (4188)	17	2	56
Swedish Orange Opaque (7274)	23	3	75

SIZE AA el

Color	Maximum Number of Capsules/Day to Meet Regulatory Limits
	WHO	CFR	JPED
Caramel Opaque	17	4	4
Swedish Orange Opaque	14	3	47
Gray Opaque	57	13
Yellow Opaque	27	7	5
White Opaque	No limit	No limit	No limit

SIZE AA

Color	Maximum Number of Capsules/Day to Meet Regulatory Limits
	WHO	CFR	JPED
Caramel Opaque	22	5	5
Swedish Orange Opaque	18	4	58
Gray Opaque	70	16
Yellow Opaque	34	9	6
White Opaque	No limit	No limit	No limit

SIZE A

Color	Maximum Number of Capsules/Day to Meet Regulatory Limits
	WHO	CFR	JPED
Caramel Opaque	26	6	6
Swedish Orange Opaque	22	5	70
Gray Opaque	85	19
Yellow Opaque	41	11	7
White Opaque	No limit	No limit

SIZE B

Color	Maximum Number of Capsules/Day to Meet Regulatory Limits
	WHO	CFR	JPED
Caramel Opaque	37	9	8
Swedish Orange Opaque	30	7	98
Gray Opaque	118	27
Yellow Opaque	58	15	10
White Opaque	No limit	No limit	No limit

SIZE C

Color	Maximum Number of Capsules/Day to Meet Regulatory Limits
	WHO	CFR	JPED
Caramel Opaque	42	10	10
Swedish Orange Opaque	35	8	112
Gray Opaque	135	31
Yellow Opaque	66	17	12
White Opaque	No limit	No limit	No limit

SIZE D

Color	Maximum Number of Capsules/Day to Meet Regulatory Limits
	WHO	CFR	JPED
Caramel Opaque	51	13	12
Swedish Orange Opaque	43	10	136
Gray Opaque	165	38
Yellow Opaque	80	21	15
White Opaque	No limit	No limit	No limit

SIZE E

Color	Maximum Number of Capsules/Day to Meet Regulatory Limits
	WHO	CFR	JPED
Caramel Opaque	64	16	15
Swedish Orange Opaque	54	9	171
Gray Opaque	207	47
Yellow Opaque	101	26	19
White Opaque	No limit	No limit	No limit