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


Neutrahist Pediatric Drops

NEUTRAHIST PEDIATRIC DROPS - chlorpheniramine maleate 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 Pediatric Drops

Drug Facts

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

Uses

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

Warnings

Do not exceed recommended dosage.

Do not use this product

  • 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
  • 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
  • symptoms do not improve within 7 days or are accompanied by a fever
  • new symptoms occur

Keep out of the reach of children.

In case of accidental 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 hrs.
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

Cherry Flavor, Citric Acid, FD and C Red #40, Glycerin, 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. CT
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 used:

Principal Display Panel and Side Panel for 30 mL Label:

NDC 60258-395-30

Neutrahist
Pediatric Drops

Antihistamine / Nasal Decongestant

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

Cherry 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

L643

Rev. 10/09


Neutrahist Pediatric Drops Packaging

Neutrahist Pediatric Drops Packaging

Neutrahist Pediatric Drops Packaging


NEUTRAHIST  PEDIATRIC DROPS
chlorpheniramine maleate, and pseudoepehdrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60258-395
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
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 9 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60258-395-30 30 mL in 1 BOTTLE None

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: 02/2010 Cypress Pharmaceutical, Inc.



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


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