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Name:Nasohist Pediatric
Manufacturer:Hawthorn Pharmaceuticals, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Nasohist Pediatric Drops

NASOHIST  PEDIATRIC - chlorpheniramine maleate and phenylephrine hydrochloride liquid 
Hawthorn Pharmaceuticals, 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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Nasohist Pediatric Drops

Drug Facts

Active ingredients                               Purpose
(in each 1 mL dropperful)
Chlorpheniramine Maleate, USP 1 mg................ Antihistamine
Phenylephrine Hydrochloride, USP 2 mg............ 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 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 controlled room temperature 20-25oC (68-77oF); excursions permitted 15-30oC (59-86oF).
[See USP Controlled Room Temperature].

Inactive ingredients

Glycerin, Orange-Vanilla Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

1-888-455-5253
M-F: 8:00 a.m. - 5:00 p.m. CST
Serious side effects associated with use of this product may be reported to this number.

Manufactured for: Hawthorn Pharmaceuticals, 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 63717-290-30


Nasohist
pediatric drops

Each dropperful (1 mL) for oral administration contains:
Chlorpheniramine Maleate........ 1 mg
Phenylephrine Hydrochloride.... 2 mg

Antihistamine / Nasal Decongestant
Sugar-Free / Alcohol Free / Dye Free

Hawthorn Pharmaceuticals, Inc.

1 fl oz (30 mL)

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

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

Manufactured for:
Hawthorn Pharmaceuticals, Inc.
Madison, MS 39110

HL178                  Rev. 11/09


Nashohist Pediatric Drops Packaging

Nasohist Pediatric Drops Packaging

Nasohist Pediatric Drops Packaging


NASOHIST   PEDIATRIC
chlorpheniramine maleate and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63717-290
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 1 mg  in 1 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 2 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor ORANGE, VANILLA Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63717-290-30 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (63717-290-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/07/2007

Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)

Revised: 12/2009 Hawthorn Pharmaceuticals, Inc.



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


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