Nohist Dm

Nohist Dm
SPL v13
SPL
SPL Set ID 6aafe912-28ff-442f-8e07-b3c5993ac943
Route
ORAL
Published
Effective Date 2012-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg) Phenylephrine (10 mg) Dextromethorphan (15 mg)
Inactive Ingredients
Glycerin Methylparaben Propylene Glycol Propylparaben Anhydrous Citric Acid Edetate Disodium Water Saccharin Sodium Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-01-06
Description

Drug Facts

Purpose

Chlorpheniramine Maleate Antihistamine Dextromethorphan HBr Antitussive (cough suppressant) Phenylephrine HCl Nasal decongestant

Medication Information

Purpose

Chlorpheniramine Maleate Antihistamine

Dextromethorphan HBr Antitussive (cough suppressant)

Phenylephrine HCl Nasal decongestant

Description

Drug Facts

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
  • temporarily restores freer breathing through the nose
Section 42229-5

Drug Facts

Warnings

Do not use

  • to sedate a child or make a child sleepy
  • 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 two 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.
Directions

Do not exceed 6 doses in a 24-hour period

Age Dose
Adults and children over 12 years of age 1 teaspoonsful (5 mL) every 4 hours
Children 6 to under 12 years of age 1/2 teaspoonsful (2.5 mL) every 4 hours
Children under 6 years of age Ask your doctor
Other Information
  • store at 20°-25°C (68°-77°F)
  • very low sodium, contains 5 mg sodium per 5 mL teaspoonful
Active Ingredients

(In each 5 mL teaspoonful)

Chlorpheniramine Maleate, USP 4 mg

Dextromethorphan HBr, USP 15 mg

Phenylephrine HCl, USP 10 mg

Inactive Ingredients

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

Questions Or Comments

Call 1-601-855-7678 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

When Using This Product

Do not exceed recommended dosage.

  • marked 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 overdose, get medical help or contact a Poison Control Center immediately.

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

Structured Label Content

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
  • temporarily restores freer breathing through the nose
Section 42229-5 (42229-5)

Drug Facts

Purpose

Chlorpheniramine Maleate Antihistamine

Dextromethorphan HBr Antitussive (cough suppressant)

Phenylephrine HCl Nasal decongestant

Warnings

Do not use

  • to sedate a child or make a child sleepy
  • 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 two 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.
Directions

Do not exceed 6 doses in a 24-hour period

Age Dose
Adults and children over 12 years of age 1 teaspoonsful (5 mL) every 4 hours
Children 6 to under 12 years of age 1/2 teaspoonsful (2.5 mL) every 4 hours
Children under 6 years of age Ask your doctor
Other Information
  • store at 20°-25°C (68°-77°F)
  • very low sodium, contains 5 mg sodium per 5 mL teaspoonful
Active Ingredients

(In each 5 mL teaspoonful)

Chlorpheniramine Maleate, USP 4 mg

Dextromethorphan HBr, USP 15 mg

Phenylephrine HCl, USP 10 mg

Inactive Ingredients

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

Questions Or Comments (Questions or Comments)

Call 1-601-855-7678 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

When Using This Product (When using this product)

Do not exceed recommended dosage.

  • marked 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 (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of the Reach of Children (Keep out of the reach of children)

In case of overdose, get medical help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:45.765899 · Updated: 2026-03-14T23:13:05.198485