ACCU TUSS DM- dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid 
Accoria, Inc

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Accu Tuss DM

Purposes

Antihistamine

Cough Suppressant

Nasal Decongestant

Active Ingredient

Dexbrompheniramine Maleate 2 mg

Dextromethorphan Hydrobromide 15 mg

Phenylephrine Hydrochloride 7.5 mg

Uses

temporarily relieves these symptoms due to the common cold, hayfever (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

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 condition, 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 mellitus

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

Keep this and all drugs out of the reach of children

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

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

Ask a doctor or pharmacist before use

if you are taking sedatives or tranquilizers.

If pregnant or breastfeeding

ask a health professional before use.

Directions

Do not exceed recommended dosage

Adults and children 12 years of age and over1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24
Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours
Children under 6 years of ageConsult a doctor.

Other Information

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients

Citric Acid, Glycerin, Sodium Benzoate, Sodium Citrate, Proylene Glycol, Purified Water, Sorbitol Solution, Strawberry Flavor, Sucralose.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-800-###-#### Mon. - Fri. (9 a.m. to 5 p.m. CST).

Package Label

AccutussdmAccu Tuss DM

ACCU TUSS DM 
dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71208-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE7.5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71208-100-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/20/202310/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)10/20/202310/21/2023
Labeler - Accoria, Inc (080467792)

Revised: 12/2023
 
Accoria, Inc