RU-HIST-D- pyrilamine maleate and phenylephrine hydrochloride tablet 
CARWIN ASSOCIATES, 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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RU-HIST-D TABLETS

Drug Facts

Active Ingredients: (in each tablet)Purpose
Phenylephrine HCl 10 mgNasal Decongestant
Pyrilamine Maleate 30 mgAntihistamine

Uses

Temporarily relieves symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • nasal congestion
  • sneezing
  • itchy nose and throat
  • itchy watery eyes

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric/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 MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

  • you may get drowsy
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery.
  • may cause excitability especially in children.

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • 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.

Do not exceed recommended dosage.

Directions

  • Adults and children 12 years and over: 1 tablet every 6 to 8 hours, not to exceed 5 tablets in 24 hours, or as directed by a doctor.
  • Children 6 years to under 12 years: ½ tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor.
  • Not recommended for children under 6 years old.

Other information

Store at 59-86° F in a dry place.

Inactive ingredients

Magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.

Distributed by:
CarWin Associates, Inc.
Cropwell, AL 35054

PRINCIPAL DISPLAY PANEL - 5 Tablet Bottle Label

NDC 15370-031-05
5 Tablets

RU-HIST-D

Pyrilamine Maleate    30 mg.
Phenylephrine HCl    10 mg.

Distributed by:
CarWin Associates, Inc.
Cropwell, AL 35054
Questions or comments?
1-866-525-4566

CARWIN
ASSOCIATES

PRINCIPAL DISPLAY PANEL - 5 Tablet Bottle Label
RU-HIST-D 
pyrilamine maleate and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15370-031
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL) Pyrilamine Maleate30 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride30 mg
Inactive Ingredients
Ingredient NameStrength
Povidones (UNII: FZ989GH94E)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
Magnesium Stearate (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeBULLETSize13mm
FlavorImprint Code 31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15370-031-10100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:15370-031-051 in 1 BOX
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/200802/15/2016
Labeler - CARWIN ASSOCIATES, INC (079217215)

Revised: 2/2016
Document Id: fb114a54-2e23-4586-9824-135fe735bd1b
Set id: ae3f15f0-d7ac-4be7-93c2-67d2ed82f4dc
Version: 3
Effective Time: 20160223
 
CARWIN ASSOCIATES, INC