M-end Dmx

M-end Dmx
SPL v9
SPL
SPL Set ID ee1fae2e-3a21-4487-9989-c7620a4a7056
Route
ORAL
Published
Effective Date 2014-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dexbrompheniramine (0.667 mg) Dextromethorphan (10 mg) Pseudoephedrine (20 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-10-13

Description

Active ingredients (in each 5 mL teaspoonful) Dexbrompheniramine Maleate 0.667 mg Dextromethorphan HBr 10 mg Pseudeophedrine HCl 20 mg

Purpose

Antihistamine Antitussive Cough Suppressant Nasal Decongestant


Medication Information

Purpose

Antihistamine



Antitussive



Cough Suppressant



Nasal Decongestant

Description

Active ingredients (in each 5 mL teaspoonful) Dexbrompheniramine Maleate 0.667 mg Dextromethorphan HBr 10 mg Pseudeophedrine HCl 20 mg

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
Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed 4 doses in a 24 hour period.

Adults and children

12 years of age

and over:



3 teaspoonfuls (15 mL)

every 6 hours, not to

exceed 12 teaspoonfuls

in 24 hours

Children 6 to under

12 years of age:







1 1/2 teaspoonfuls

(7.5 mL) every 6 hours,

not to exceed 6

teaspoonfuls in

24 hours

Children under 6

years of age:

Consult a Physician.



Drug Facts

Active ingredients

(in each 5 mL teaspoonful)


Dexbrompheniramine Maleate 0.667 mg

Dextromethorphan HBr 10 mg

Pseudeophedrine HCl 20 mg

Other Information

Store at 59°-86°F (15°-30°C)

Product Packaging

Inactive Ingredients

Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, Tutti Frutti Flavor.

Questions? Comments?

Call 1-423-493-9170

Do Not Use This Product
  • 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 product
When Using This Product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizes may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

Keep Out of Reach of Children.

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

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


Structured Label Content

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine



Antitussive



Cough Suppressant



Nasal Decongestant

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed 4 doses in a 24 hour period.

Adults and children

12 years of age

and over:



3 teaspoonfuls (15 mL)

every 6 hours, not to

exceed 12 teaspoonfuls

in 24 hours

Children 6 to under

12 years of age:







1 1/2 teaspoonfuls

(7.5 mL) every 6 hours,

not to exceed 6

teaspoonfuls in

24 hours

Children under 6

years of age:

Consult a Physician.



Drug Facts

Active ingredients

(in each 5 mL teaspoonful)


Dexbrompheniramine Maleate 0.667 mg

Dextromethorphan HBr 10 mg

Pseudeophedrine HCl 20 mg

Other Information (Other information)

Store at 59°-86°F (15°-30°C)

Product Packaging

Inactive Ingredients (Inactive ingredients)

Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, Tutti Frutti Flavor.

Questions? Comments?

Call 1-423-493-9170

Do Not Use This Product (Do not use this product)
  • 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 product
When Using This Product (When using this product)
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizes may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

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

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes


Advanced Ingredient Data


Raw Label Data

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