Nasohist DM Pediatric

Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 1mg in 1mL, Dextromethorphan Hydrobromide 3mg in 1mL, Phenylephrine Hydrochloride 2mg in 1mL
Labeler: Hawthorn Pharmaceuticals, Inc.
NDC Code: 63717-325

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.

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

PurposeAntihistamine
Cough Suppressant
Nasal Decongestant

Usestemporarily 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 childis 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
AGEDOSE*
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 informationStore at Controlled Room Temperature 20°- 25°C (68°- 77°F); excursions permitted 15°- 30°C (59°- 86°F). [See USP Controlled Room Temperature].

Inactive ingredientsGlycerin, 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 PackagingThe 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
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63717-325
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate1 mg  in 1 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide3 mg  in 1 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63717-325-301 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/09/2011
Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)

Revised: 06/2011
 
Hawthorn Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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