HIST-PSE  - pseudoephedrine hydrochloride and triprolidine hydrochloride liquid 
Cypress Pharmaceutical, Inc.

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Hist-PSE Drops

Drug Facts

Active ingredients                                               Purpose
(in each 1 mL dropperful)
Pseudoephedrine Hydrochloride, USP 10 mg........ Nasal Decongestant
Triprolidine Hydrochloride, USP 0.938 mg...................... Antihistamine

Uses

temporarily 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
  

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 is

taking 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 the 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:	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 information

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

Inactive ingredients

Citric Acid, Cotton Candy Flavor, Colorcon Red, Glycerin, Propylene Glycol, Purified Water,
Sodium Saccharin, Sodium Citrate, 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).

04/10    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)

Side Panel:

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  04/10

HIST-PSE  pseudoephedrine hydrochloride and triprolidine hydrochloride   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 60258-201 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 10 mg  in 1 mL Triprolidine Hydrochloride (Triprolidine) Triprolidine Hydrochloride .938 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor COTTON CANDY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 60258-201-30 1 BOTTLE In 1 CARTON contains a BOTTLE 1 30 mL In 1 BOTTLE This package is contained within the CARTON (60258-201-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/16/2010

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 05/2010Cypress Pharmaceutical, Inc.