CERTI-SINE- phenylephrine hydrochloride tablet 
Certified Safety Manufacturing

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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CERTI-SINE™

Drug Facts

Active Ingredients (each tablet)

Phenylephrine HCl 5 mg

Purpose

Nasal decongestant

Uses

Warnings

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 health professional before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland.

Stop use and ask a doctor if

  • new symptoms occur
  • symptoms do not improve within 7 days
  • redness or swelling are present
  • you get nervous, dizzy or sleepless.

If pregnant or breast-feeding

  • ask a health professional before use.

Keep out of the reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Directions

  • Adults and children 12 years of age and older
Take 2 tablets every 4 hours as needed.
Do not take more than 12 tablets in 24 hours.
  • Children under 12 years of age
Do not use this adult strength product without first speaking to your doctor.

Other information

Inactive ingredients

Questions?

Call 1-800-854-7474

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Pouch Box

Tamper evident
packaging:
Do not use if
open or torn.

This package for
households
without children

See New Warnings
Information

Compare to Sudafed PE ®
CERTI-SINE
5 mg Phenylephrine HCl

Principal Display Panel - 5 mg Tablet Pouch Box
CERTI-SINE 
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48083-330
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 271
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48083-330-2725 in 1 BOX12/29/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:48083-330-3050 in 1 BOX12/29/2017
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:48083-330-33125 in 1 BOX12/29/2017
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:48083-330-36250 in 1 BOX12/29/2017
42 in 1 POUCH; Type 0: Not a Combination Product
5NDC:48083-330-39500 in 1 BOX12/29/2017
52 in 1 POUCH; Type 0: Not a Combination Product
6NDC:48083-330-411000 in 1 BOX12/29/2017
62 in 1 POUCH; Type 0: Not a Combination Product
7NDC:48083-330-3150 in 1 BOX12/29/2017
72 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/29/2017
Labeler - Certified Safety Manufacturing (788460483)

Revised: 4/2018
Document Id: 262daeb0-6a7b-4fc6-b010-75b22c86c7f8
Set id: 6825b90f-133c-457d-b75b-4a630c0a2030
Version: 1
Effective Time: 20180412
 
Certified Safety Manufacturing