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Name:Brompheniramine Phenylephrine Dm
Manufacturer:Macoven Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


BROMPHENIRAMINE PHENYLEPHRINE DM LIQUID

BROMPHENIRAMINE PHENYLEPHRINE DM - brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Macoven Pharmaceuticals

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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BROMPHENIRAMINE
PHENYLEPHRINE DM
LIQUID

Drug Facts

Active ingredients (in each 5 mL teaspoonful) Purpose
Brompheniramine Maleate 4 mg Antihistamine
Dextromethorphan HBr 20 mg Cough Suppressant
Phenylephrine HCl 10 mg Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other 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

  • 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

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • a persistent or chronic cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

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

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

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately. 1-800-222-1222

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 6 years of age: Consult a doctor

Other Information

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive ingredients

Bubblegum Flavor, Citric Acid, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Question? Comments?

Call 1-877-622-6836

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 44183-313-16

BROMPHENIRAMINE/
PHENYLEPHRINE DM
LIQUID

Antihistamine ■ Cough Suppressant ■ Decongestant

Sugar Free ■ Alcohol Free ■ Dye Free ■ Gluten Free

Each teaspoonful (5 mL) for oral
administration contains:
Brompheniramine Maleate 4 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg

Bubblegum Flavor

This bottle is not to be dispensed to consumer.

Tamper evident by foil seal under cap. Do not use
if foil seal is broken or missing.

Dispense in a tight container with a child-resistant cap.

Manufactured for:

MACOVEN
PHARMACEUTICALS
Magnolia, TX 77354

16 fl. oz. (473 mL)

Principal Display Panel - 473 mL Bottle Label

BROMPHENIRAMINE PHENYLEPHRINE DM 
brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44183-313
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 4 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
METHYLPARABEN  
POTASSIUM CITRATE  
POTASSIUM SORBATE  
PROPYLPARABEN  
PROPYLENE GLYCOL  
WATER  
SORBITOL  
SUCRALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44183-313-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/01/2011

Labeler - Macoven Pharmaceuticals (832591965)

Revised: 03/2011 Macoven Pharmaceuticals



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


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