DEXBROMPHENIRAMINE-DM-PHENYLEPHRINE 2-15-7.5- dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
AddGen Pharmaceuticals, 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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Active ingredients

(in each 5 mL teaspoonful)

Dexbrompheniramine Maleate 2 mg

Dextromethorphan Hydrobromide 15 mg

Phenylephrine Hydrochloride 7.5mg

Purpose

Antihistamine
Antitussive
Nasal Decongestant

Uses

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

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
  • 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

Ask a doctor or pharmacist before use

if you are

taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • be careful 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. A persistent cough may be a sign 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 overdose, get medical help or contact a Poison Control Center right away.

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 a 24
hours
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
Children under
6 years of age:
Consult a doctor.

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Anhydrous Citric Acid, Glycerin, Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol Solution.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number.
Call 1-800-882-1041
Mon. - Fri. (8 a.m. to 5 p.m. CST).

label

DEXBROMPHENIRAMINE-DM-PHENYLEPHRINE 2-15-7.5 
dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83521-111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83521-111-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2023
Labeler - AddGen Pharmaceuticals, Inc. (118994799)

Revised: 7/2023
Document Id: 0019528c-2f66-ef52-e063-6394a90a37bb
Set id: 0019528c-2f65-ef52-e063-6394a90a37bb
Version: 1
Effective Time: 20230709
 
AddGen Pharmaceuticals, Inc.