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Information about Sudafed, a nasal decongestant medication containing pseudoephedrine hydrochloride. It includes details on active ingredients, uses, warnings, directions, and inactive ingredients. Users are advised to consult a doctor before use, especially if they have certain health conditions or are taking certain medications.
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SUDAFED- ps eudoephedrine hydrochloride tablet, coated Johns on & Johns on Cons umer Inc., McNeil Cons umer Healthcare Divis ion Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
SUDAFED Drug Facts Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg Purpos e Nasal decongestant Us es temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies Warnings Do not us e if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. As k a doctor before us e if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When us ing this product do not exceed recommended dos e Stop us e and as k a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever If pregnant or breas t-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Directions adults and children take 2 tablets every 4 to 6 hours do not take more than 8 tablets in 24 hours ®
12 years and over do not take more than 8 tablets in 24 hours children ages 6 to 11 years take 1 tablet every 4 to 6 hours do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age Other information store between 20 - 25°C (68 - 77°F) do not us e if carton is opened or if blis ter unit is broken see side panel for lot number and expiration date Inactive ingredients carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, shellac, sodium starch glycolate, talc, titanium dioxide Ques tions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect) PRINCIPAL DISPLAY PANEL SINUS NDC 50580-545- SUDAFED CONGESTION Pseudoephedrine HCl, Nasal Decongestant SINUS PRESSURE
pseudoephedrine hydrochloride tablet, coated Product Information Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:50 58 0 - Route of Ad minis tration O RAL Active Ing redient/Active Moiety Ing redient Name Basis o f Streng th Streng th Pse udo e phe drine Hydro c hlo ride (UNII: 6 V9 V2RYJ8 N) (Pse udo e phe drine - UNII:7CUC9 DDI9 F) Pse udo e phe drine Hydro c hlo ride 30 mg Inactive Ing redients Ing redient Name Streng th c a rna uba wa x (UNII: R12CBM0 EIZ) silic o n dio xide (UNII: ETJ7Z6 XBU4) D&C ye llo w NO. 10 (UNII: 35SW5USQ 3G) a luminum o xide (UNII: LMI26 O 6 9 33) FD&C re d NO. 4 0 (UNII: WZB9 127XO A) FD&C ye llo w NO. 6 (UNII: H77VEI9 3A8 ) fe rro so fe rric o xide (UNII: XM0 M8 7F357) ma g ne sium ste a ra te (UNII: 70 0 9 7M6 I30 ) c e llulo se , mic ro c rysta lline (UNII: O P1R32D6 1U) po lye thyle ne g lyc o ls (UNII: 3WJQ 0 SDW1A) po lyvinyl a lc o ho l (UNII: 532B59 J9 9 0 ) so dium sta rc h g lyc o la te type a po ta to (UNII: 58 56 J3G2A2) she lla c (UNII: 46 N10 7B71O ) ta lc (UNII: 7SEV7J4R1U) tita nium dio xide (UNII: 15FIX9 V2JP) Product Characteristics Color RED^ S core no sc o re S hap e RO UND^ S iz e 7mm Flavor Imp rint Cod e SU Contains Packag ing
1 NDC:50 58 0 -545-24 3 in 1 CARTO N 1 8 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n Pro duc t 2 NDC:50 58 0 -545-72 3 in 1 PACKAGE 2 NDC:50 58 0 -545-24 3 in 1 CARTO N 2 8 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n Pro duc t 3 NDC:50 58 0 -545-48 6 in 1 CARTO N
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 3 8 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n Pro duc t
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date O TC MO NO GRAPH FINAL pa rt341 10 /0 1/20 11
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