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


Nasohist DM Pediatric Drops

NASOHIST DM PEDIATRIC - chlorpheniramine maleate, dextromethorphan hydrobromide 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 DM Pediatric Drops

Drug Facts

Active ingredients
(in each 1 mL dropperful)

Chlorpheniramine Maleate, USP 1 mg
Dextromethorphan Hydrobromide, USP 3 mg
Phenylephrine Hydrochloride, USP 2 mg

Purpose

Antihistamine
Cough Suppressant
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
  • 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

  • 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 as 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 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,
or as directed by a doctor.
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°- 25°C (68°- 77°F); excursions permitted 15°- 30°C (59°- 86°F). [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 labeling currently used:

Principal display panel and side panel for 30 mL label:

NDC 63717-325-30

nasohist DM
pediatric drops

Antihistamine / Cough Suppressant / Nasal Decongestant

Each dropperful (1 mL) for oral
administration contains:

Chlorpheniramine Maleate........................1 mg
Dextromethorphan HBr...........................3 mg
Phenylephrine HCl.................................2 mg

Sugar Free / Alcohol Free
Dye Free

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.

See package insert for full prescribing information.

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

HL177  Rev. 05/11


Nasohist DM Pediatric Drops Packaging



Nasohist DM Pediatric Drops Packaging



Nasohist DM Pediatric Drops Packaging






































NASOHIST  DM PEDIATRIC
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63717-325
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
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 3 mg  in 1 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Propylene Glycol  
Water  
Sodium Citrate  
Saccharin Sodium  
Sorbitol  
Product Characteristics
Color      Score     
Shape Size
Flavor ORANGE, VANILLA Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63717-325-30 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (63717-325-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/09/2011

Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)

Revised: 06/2011 Hawthorn Pharmaceuticals, Inc.



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


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