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Name:Nohist Dm
Manufacturer:Larken Laboratories, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


NoHist DM

NOHIST DM  - chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Larken Laboratories, 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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NoHist DM

Drug Facts

Active Ingredients

In each 5 mL (1 teaspoonful) clear, grape flavored liquid

Chlorpheniramine Maleate, USP   4 mg

Dextromethorphan HBr, USP   15 mg

Phenylephrine HCl, USP   10 mg

Purpose

Chlorpheniramine Maleate          Antihistamine

Dextromethorphan HBr                Antitussive

Phenylephrine HCl                         Nasal decongestant

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis):

  • cough due to minor throat and bronchial irritation
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis.
  • Temporarily restores freer breathing through the nose

Warnings

Do not exceed recommended dosage.

Do not use

  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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.

If pregnant or breast-feeding

  • ask a health professional before use.

Keep out of the reach of children

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

Do not exceed 6 doses in a 24-hour period

Age Dose
Adults and children over 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours
Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 to 6 hours
Children under 6 years of age Ask your doctor

Other Information

store at 20°-25°C (68°-77°F)

Inactive Ingredients

Calcium saccharin, citric acid, edetate disodium, glycerin, grape flavoring, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate

Questions or Comments

Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

Principal Display Panel

Figure 1: 16 oz Bottle Label

8adb052e-figure-01

NOHIST DM 
chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68047-186
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN CALCIUM  
ANHYDROUS CITRIC ACID  
EDETATE DISODIUM  
GLYCERIN  
METHYLPARABEN  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SODIUM CITRATE  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68047-186-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/06/2011

Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE

Revised: 01/2011 Larken Laboratories, Inc.



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


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