Atovaquone proguanil labels and packages: Difference between revisions
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==Labels And Packages== | ==Labels And Packages== | ||
Principal Display Panel | Principal Display Panel | ||
NDC 0173-0675-01 | NDC 0173-0675-01 | ||
MALARONE® | MALARONE® | ||
(atovaquone and proguanil HCl) | (atovaquone and proguanil HCl) | ||
Tablets | Tablets | ||
Each tablet contains 250 mg atovaquone and 100 mg proguanil HCl. | Each tablet contains 250 mg atovaquone and 100 mg proguanil HCl. | ||
Rx only | Rx only | ||
100 Tablets | 100 Tablets | ||
See accompanying prescribing information for Dosage and Administration. | See accompanying prescribing information for Dosage and Administration. | ||
Store at 25oC (77oF); excursions permitted to 15o to 30oC (59oto 86oF) (see USP Controlled Room Temperature). | Store at 25oC (77oF); excursions permitted to 15o to 30oC (59oto 86oF) (see USP Controlled Room Temperature). | ||
Do not use if printed safety seal under cap is broken or missing. | Do not use if printed safety seal under cap is broken or missing. | ||
GlaxoSmithKline | GlaxoSmithKline | ||
Research Triangle Park, NC 27709 | Research Triangle Park, NC 27709 | ||
Made in Canada | Made in Canada | ||
Rev. 3/10 | Rev. 3/10 | ||
A079205 | A079205 | ||
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|} | |} | ||
Principal Display Panel | Principal Display Panel | ||
NDC 0173-0676-01 | NDC 0173-0676-01 | ||
MALARONE® | MALARONE® | ||
(atovaquone and proguanil HCl) | (atovaquone and proguanil HCl) | ||
Pediatric Tablets | Pediatric Tablets | ||
Each tablet contains 62.5 mg atovaquone and 25 mg proguanil HCl. | Each tablet contains 62.5 mg atovaquone and 25 mg proguanil HCl. | ||
Rx only | Rx only | ||
100 Tablets | 100 Tablets | ||
See accompanying prescribing information for Dosage and Administration. | See accompanying prescribing information for Dosage and Administration. | ||
Store at 25oC (77oF); excursions permitted to 15o to 30oC (59oto 86oF) (see USP Controlled Room Temperature). | Store at 25oC (77oF); excursions permitted to 15o to 30oC (59oto 86oF) (see USP Controlled Room Temperature). | ||
Do not use if printed safety seal under cap is broken or missing. | Do not use if printed safety seal under cap is broken or missing. | ||
GlaxoSmithKline | GlaxoSmithKline | ||
Research Triangle Park, NC 27709 | Research Triangle Park, NC 27709 | ||
Made in Canada | Made in Canada | ||
Rev. 3/10 | Rev. 3/10 | ||
A079206<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887 | publisher = | date = | accessdate = }}</ref> | A079206<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887 | publisher = | date = | accessdate = }}</ref> | ||
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|- | |- | ||
|} | |} | ||
==References== | ==References== |
Latest revision as of 05:37, 7 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Labels And Packages
Principal Display Panel
NDC 0173-0675-01
MALARONE®
(atovaquone and proguanil HCl)
Tablets
Each tablet contains 250 mg atovaquone and 100 mg proguanil HCl.
Rx only
100 Tablets
See accompanying prescribing information for Dosage and Administration.
Store at 25oC (77oF); excursions permitted to 15o to 30oC (59oto 86oF) (see USP Controlled Room Temperature).
Do not use if printed safety seal under cap is broken or missing.
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Canada
Rev. 3/10
A079205
Principal Display Panel
NDC 0173-0676-01
MALARONE®
(atovaquone and proguanil HCl)
Pediatric Tablets
Each tablet contains 62.5 mg atovaquone and 25 mg proguanil HCl.
Rx only
100 Tablets
See accompanying prescribing information for Dosage and Administration.
Store at 25oC (77oF); excursions permitted to 15o to 30oC (59oto 86oF) (see USP Controlled Room Temperature).
Do not use if printed safety seal under cap is broken or missing.
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Canada
Rev. 3/10
A079206[1]
References
Adapted from the FDA Package Insert.