RU-HIST-D- pyrilamine maleate and phenylephrine hydrochloride liquid 
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 LIQUID

Drug Facts

Active ingredients: (in each 5 ml.)Purpose
Phenylephrine HCl 10 mg.Nasal Decongestant
Pyrilamine Maleate 30 mg.Antihistamine

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 teaspoon every 6 to 8 hours, not to exceed 5 teaspoons in 24 hours, or as directed by a doctor.
  • Children 6 years to under 12 years: 1/2 teaspoon every 6 to 8 hours, not to exceed 3 teaspoons 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

Glycerin, potassium benzoate, povidone, purified water, sucralose, xanthan gum and xylitol.

CARWIN ASSOCIATES
Cropwell, AL 35054

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

NDC 15370-032-04

RU-HIST-D
LIQUID

15 mL
Dye Free, Sugar Free,
Alcohol Free

CARWIN
ASSOCIATES
Cropwell, AL 35054

Questions or comments?
Tel. 866-525-4566

Each Teaspoon (5 ml) contains:
Pyrilamine Maleate...30 mg.
Phenylephrine HCI...10 mg.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label
RU-HIST-D 
pyrilamine maleate and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15370-032
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL) Pyrilamine Maleate30 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Xylitol (UNII: VCQ006KQ1E)  
Xanthan Gum (UNII: TTV12P4NEE)  
Povidones (UNII: FZ989GH94E)  
Sucralose (UNII: 96K6UQ3ZD4)  
Potassium Benzoate (UNII: 763YQN2K7K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15370-032-16475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:15370-032-042 in 1 BOX
215 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/201202/15/2016
Labeler - CARWIN ASSOCIATES, INC (079217215)

Revised: 2/2016
Document Id: 40aa3396-1f2a-405d-830f-27f2149f5954
Set id: cf0a266c-d092-4a4d-b2d0-09a3a2a5c469
Version: 3
Effective Time: 20160223
 
CARWIN ASSOCIATES, INC