NON-DROWSY NASAL DECONGESTANT PE- phenylephrine hcl tablet, film coated 
Strive Pharmaceuticals Inc.

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.

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Non-Drowsy Nasal Decongestant
Phenylephrine Hydrochloride Tablets 10mg

Phenylephrine HCl 10mg

microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, FD&C yellow# 6, FD&C red #40, titanium dioxide, D&C yellow #10

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

adults and children 12 years and over
  • 1 tablet every 4 hours
  • Do not take more than 6 tablets in 24 hours
children under 12 years

Ask a doctor

* temporarily relieves sinus congestion and pressure

* temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

*Do not use 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.

*Ask a doctor before use if you have-

*When using this product do not exceed recommended dose.

*Stop use and ask a doctor if

*If pregnant or breast-feeding, ask a health professional before use.

*Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Nasal Decongestant

100

NON-DROWSY NASAL DECONGESTANT PE 
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 1000000 (UNII: HZ58M6D839)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code S71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70692-100-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product02/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/22/2018
Labeler - Strive Pharmaceuticals Inc. (080028013)

Revised: 10/2020
Document Id: b1935570-d420-ab2e-e053-2995a90ae8d8
Set id: 64e2a606-3d47-f255-e053-2991aa0a519d
Version: 3
Effective Time: 20201013
 
Strive Pharmaceuticals Inc.