PHENYLEPHRINE HYDROCHLORIDE- phenylephrine hydrochloride tablet, coated 
AAA Pharmaceutical, 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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Phenylephrine HCl Tablets

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 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 doctor or pharmacist before taking this product.

Ask a doctor before use if you have

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

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-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.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C red #40, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

RESTORE u

NDC 57344-131-03

COMPARE TO THE ACTIVE
INGREDIENT IN SUDAFED PE®
NASAL DECONGESTANT

MAXIMUM
STRENGTH

NON-DROWSY

Nasal Decongestant PE

Phenylephrine HCl

Relieves: • Nasal & Sinus Congestion • Sinus Pressure

36 TABLETS - 10 mg each

Principal Display Panel - 36 Tablet Blister Pack Carton
PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-131
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color RED Score no score
Shape ROUND Size 7mm
Flavor Imprint Code A;131
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57344-131-02 1 in 1 CARTON
1 18 in 1 BLISTER PACK
2 NDC:57344-131-03 2 in 1 CARTON
2 18 in 1 BLISTER PACK
3 NDC:57344-131-04 4 in 1 CARTON
3 18 in 1 BLISTER PACK
4 NDC:57344-131-05 1 in 1 CARTON
4 150 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/22/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)

Revised: 1/2013
Document Id: 6e19e526-1f1c-41ba-90ff-bbaff1e3ecf8
Set id: 3ced476d-81c4-42c1-af09-dfa771f94690
Version: 1
Effective Time: 20130104
 
AAA Pharmaceutical, Inc.