COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 2 December 2015, a delegate of the Secretary of the Department of Health, on the application of Reckitt Benckiser Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of the following goods that will not conform with the requirements of paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine, in that the medicine labels do not include all of the new warning statements that will be required by the legislative instrument made by the Minister under subsection 3(5A) of the Act, from 12 December 2015.
AUST R | Product name | Batch numbers [pack sizes] |
15357 | CARDIPRIN 100 aspirin 100mg tablet blister pack | 513407 [180-tablet packs] 513507 [90-tablet packs] |
15356 | DISPRIN DIRECT CHEWABLES aspirin 300mg dispersible tablet strip | 519009 [24-tablet packs] |
53682 | DISPRIN MAX aspirin 500mg dispersible tablet strip pack | 517707 [16-tablet packs] |
59901 | DISPRIN ORIGINAL aspirin 300mg dispersible tablet strip pack | 521209 [24-tablet packs] |
59902 | SOLPRIN aspirin 300mg dispersible tablet strip pack (reformulation) | 518205 [96-tablet packs] |
10021
| DISPRIN FORTE dispersible tablet strip pack | 505709 528209 [24-tablet packs] |
15357
| CODIS tablet strip pack | 511005, 526107 [24-tablet packs] |
65640 | NUROFEN COLD & FLU WITH DECONGESTANT tablet blister pack ibuprofen 200mg pseudoephedrine 30mg | BJ065 [24-tablet packs] |
156293 | NUROFEN ZAVANCE 256mg ibuprofen sodium sugar coated tablet blister pack | BN360, BN375, BN476, BL544, BJ091, BL510, BN375 [12-tablet packs]; BN999, BN486, BN049, BR067, BR068, BM553, BN038, BN039, BN486, BN049, BR067, BM463, BM522, BE988, BJ167, BN037 [24-tablet packs]; BM367, BG424 [48-tablet packs]; BM028, BM036, BN336, BN351 [72-tablet packs]; BN128, BD412, BM367 [96-tablet packs] |
156294 | NUROFEN ZAVANCE 256mg ibuprofen sodium sugar coated capsule shaped tablet blister pack | BL274, BN260, BN276, BH097, BJ414, BM241, BL273 [12-caplet packs]; BL932, BL917, BL984, BL958, BM641, BN295, BN296, BR758, BR804, BG982 [24-caplet packs] |
163477 | NUROFEN ZAVANCE LIQUID CAPSULES ibuprofen 200mg soft capsule blister pack | BL264, BL915, BM346, BN517, BS548 [10-capsule packs]; BL861, BM718, BM717, BR027, BN575, BN580 [20-capsule blister packs]; BM823, BM826, BL522, BN203, BR106, BK683 [40-capsule packs] |
127273 | Nurofen Tablets ibuprofen 200 mg bottle | BN026, BM955, BR170, BR191, BR278, BR552, BR592, BR697, BT063 [96-tablet bottles] |
127272
| Nurofen Tablets ibuprofen 200 mg blister pack | BG476 [8-tablet pack] |
127287 | Nurofen Caplets ibuprofen 200 mg capsule shaped tablet blister pack | BL223 [24-caplet pack] |
108772 | NUROFEN FOR CHILDREN BABY 3+ MONTHS strawberry flavour ibuprofen 40mg/ml oral liquid bottle (new) | J01, J02, J03 [50 mL] |
181936 | NUROFEN COLD & FLU PE tablets blister pack | BK179, BR267 [48-tablet packs] |
187599 | NUROFEN SINUS PAIN PE tablets blister pack | BK135 [24-tablet packs] |
116620 | NUROFEN PLUS tablet blister pack (reformulation) | BN828, BR796 [12-tablet packs]; BN050, BR816 [24-tablet packs]; BR180, BR182, BR243, BR181, BR160, BR261, BR243, BS344, BS403, BS343, BS387, BS344, BS920, BS896, BS918, BS920 [30-tablet packs] |
142080 | NUROFEN BACK PAIN ibuprofen lysine 342mg capsule shaped tablet blister pack | BM828, BN971, BN972, BR724 [24-caplet packs] |
96215 | NUROFEN MIGRAINE PAIN ibuprofen lysine 342mg tablet blister pack | BK134, BL648, BL688, BM991, BR249, BR250, BS604 [24-caplet packs] |
134618
| NUROFEN PERIOD PAIN ibuprofen lysine 342mg tablet blister pack | BM852, BR233, BS518, BS519 [24-caplet packs] |
120354
| NUROFEN TENSION HEADACHE ibuprofen lysine 342mg tablet blister pack | BE506, BJ459, BM815, BR746 [24-caplet packs] |
157020 | STREPFEN INTENSIVE SUGAR FREE ORANGE flurbiprofen 8.75mg lozenge blister pack (reformulation) | BK397 [16-lozenge packs] |
134660 | LEMSIP MAX MULTI-RELIEF COLD & FLU HOT DRINK Lemon Flavour oral powder sachet | 520411, 524412 [10-sachet packs] |
133862 | LEMSIP MAX COLD & FLU WITH DECONGESTANT HOT DRINK Lemon Flavour oral powder sachet | 514911 [10-sachet packs] |
133863 | LEMSIP MAX COLD & FLU WITH DECONGESTANT HOT DRINK Blackcurrant Flavour oral powder sachet | 505611, 518313 [10-sachet packs] |
11247 | Savlon Antiseptic Cream Tube | 4942, 5404, 5404A [30 g tubes]; 4937 [50 g tubes] |
The consent applies to the nominated batches and pack sizes, but only until 31 August 2016.
The consent is subject to the following conditions:
- The labels to which this consent applies are those previously approved by the TGA for these products.