Sudafed Drug Facts: Pseudoephedrine Hydrochloride Tablet, Exercises of Mathematics

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.

Typology: Exercises

2020/2021

Uploaded on 05/05/2021

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SUDAFED- ps eudoe phedrine hydro chlo ride tablet, co ated
Johnson & Johnson Cons umer Inc., Mc Neil 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)
Pse udoephedrine HCl 30 mg
Purpose
Nasal dec onge stant
Us es
temporarily r elieves sinus c ongestion and pressure
temporarily r elieves nasal co nges tion due to the common co ld, hay feve r o r o ther upper respir atory
alle rg ies
Warnings
Do not us e if yo u are now taking a presc ription monoamine o xidase inhibitor (MAOI) (certain drugs fo r
depression, psychiatric or emotio nal co nditions, o r Parkinson's disease), or f or 2 weeks after s topping
the MAOI drug. If you do not know if your prescriptio n drug contains an MAOI, ask a doctor or
pharmacist before taking this produc t.
As k a do cto r before use if you have
heart dise ase
high blood pr es sure
thyroid dis ease
diabetes
trouble urinating due to an enlarged prostate gland
When using this product do not exce ed recommended dos e
Stop use and as k a doctor if
nervo usness, dizziness , or sleeplessnes s o cc ur
symptoms do not improve within 7 days or occ ur with a fever
If pregnant or breas t-feeding, ask a health pro fe ss ional before use.
Keep out o f reac h of children. In case of overdos e, g et medic al help or contact a Poiso n Control
Center rig ht away. (1-8 00-222-1222)
Direc tions
adults and chi ldren take 2 tablets e ver y 4 to 6 hours
do not take more than 8 tablets in 24 hours
®
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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

  • CONGESTION MAXIMUM STRENGTH 24 TABLETS 30 mg EACH ‡Actual Pill Size NON-DROWSY ®

SUDAFED

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

Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date

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

Marketing Information

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

Labeler - Johns on & Johns on Cons umer Inc., McNeil Cons umer Healthcare Divis ion (878046358)

Revised: 3/