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Name:Neutrahistpdx Drops
Manufacturer:Cypress Pharmaceutical, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Neutrahist PDX Drops

NEUTRAHIST PDX DROPS - chlorpheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride liquid 
Cypress 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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Neutrahist PDX Drops

Drug Facts

Active ingredients                                     Purpose
(in each 1 mL dropperful)
Chlorpheniramine Maleate, USP 0.8 mg....................Antihistamine
Dextromethorphan Hydrobromide, USP 3 mg.............Cough Suppressant
Pseudoephedrine Hydrochloride, USP 9 mg..............Nasal Decongestant

Uses

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

Warnings

Do not exceed recommended dosage.

Do not use this product

•under 4 years of age
•in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

•a breathing problem such as chronic bronchitis •glaucoma
•a persistent or chronic cough such that occurs with asthma
•a cough that occurs with too much phlegm (mucus) •heart disease
•high blood pressure •thyroid disease •diabetes mellitus

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

•excitability may occur, especially in children
•may cause marked drowsiness
•sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

•nervousness, dizziness, or sleeplessness occur
•cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied
by a fever, rash or persistent headache. These could be signs of a serious condition.
•new symptoms occur

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Administer each dose four times per day using provided dropper.
Do not exceed recommended dosage.

AGE DOSE*
Children 6 to under 12 years of age:
2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hours.
Children under 6 years of age:
Consult a physician.
*In mild cases or in particularly sensitive patients, less frequent or
reduced doses may be adequate.

Other information

Store at 77oF (25oC); excursions permitted 15o to 30oC (59o-86oF)
Protect from freezing.

Inactive ingredients

Citric Acid,  FD and C Blue #1, FD and C Red #40, Glycerin, Grape Flavor, Propylene
Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol.

Questions? Comments?

1-800-856-4393
M-F: 8:00 a.m. - 5:00 p.m. CCT
Serious side effects associated with use of this product may be reported to this number

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

PRODUCT PACKAGING

The packaging below represents the labeling currently being used.

NDC 60258-396-30

Neutrahist PDX Drops

Antihistamine/Cough Suppressant
Nasal Decongestant


Each dropperful (1 mL) for oral administration contains:
Chlorpheniramine Maleate, USP............ 0.8 mg
Dextromethorphan Hydrobromide, USP..... 3 mg
Pseudoephedrine Hydrochloride, USP....... 9 mg

Grape Flavor
Sugar Free/Alcohol Free


Cypress Pharmaceutical, Inc.

1 fl oz (30 mL)


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.

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

L644

Rev. 05/09

NeutrahistPDXdrops Packaging


NeutrahistPDXdrops Packaging


NeutrahistPDXdrops Packaging


NeutrahistPDXdrops Packaging


NEUTRAHIST  PDX DROPS
chlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60258-396
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 0.8 mg  in 1 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 3 mg  in 1 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 9 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60258-396-30 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE (60258-396-30)
1 NDC:60258-396-30 30 mL in 1 BOTTLE This package is contained within the CARTON (60258-396-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/30/2007

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 07/2009 Cypress Pharmaceutical, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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