Hist-PSE

Dosage form: liquid
Ingredients: Pseudoephedrine Hydrochloride 10mg in 1mL, Triprolidine Hydrochloride .938mg in 1mL
Labeler: Cypress Pharmaceutical, Inc.
NDC Code: 60258-201

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.

Hist-PSE Drops

Drug Facts Active ingredients                                             
(in each 1 mL dropperful)
Pseudoephedrine Hydrochloride, USP 10 mg
Triprolidine Hydrochloride, USP 0.938 mg

PurposeNasal Decongestant
Antihistamine

UsesTemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • nasal congestion
  • reduces swelling of nasal passages
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Enter section text here

Warnings Do not exceed recommended dosage.

Do not use this product
  • if you or your child 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 you or your child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you or your child have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to the enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if you or your child istaking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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.

Directions
  • Do not exceed recommended dosage.
  • Use only with enclosed dropper. Do not use with any other device.
Adults and children 12 years
of age and over:
2.67 mL every 4 to 6 hours, not to
exceed 4 doses in 24 hours.
Children 6 to under 12 years
of age:
1.33 mL every 4 to 6 hours, not to
exceed 4 doses in 24 hours.
Children under 6 years of age:
Consult a doctor.

Other informationStore at controlled room temperature 59o-86oF (15o-30oC)

Inactive ingredientsCitric Acid, Cotton Candy Flavor, FD&C Blue #1, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?Seek medical assistance immediately for serious side effects associated with the use of this product.
Serious side effects may be reported to this number: 1-800-856-4393 (Mon-Fri 8 a.m. to 5 p.m. CST).

02/12    I374

Product Packaging:The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 30 mL Label:

NDC 60258-201-30


Hist-PSE
Drops
(pseudoephedrine HCl/triprolidine HCl oral solution)

Nasal Decongestant
Antihistamine

Each dropperful (1 mL) for oral administration, contains:
Pseudoephedrine HCl, USP....... 10 mg
Triprolidine HCl, USP............ 0.938 mg

Sugar Free · Alcohol Free
Cotton Candy Flavor

CYPRESS
PHARMACEUTICAL, INC.

1 fl oz (30 mL)


For complete information on use, see attached insert.

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child-resistant cap.

Manufactured for:
Cypress Pharmaceutical, Inc.
Madison, MS 39110

L694  02/12




HIST-PSE 
pseudoephedrine hydrochloride and triprolidine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60258-201
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride10 mg  in 1 mL
Triprolidine Hydrochloride (Triprolidine) Triprolidine Hydrochloride.938 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium Dihydrate 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:60258-201-301 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/16/2010
Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 04/2012
 
Cypress Pharmaceutical, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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