Accu Tuss DM

Manufacturer
Accoria, Inc
Effective date
2022-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:23:53

Label at a glance#

ProductAccu Tuss DM
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, DEXBROMPHENIRAMINE MALEATE
Label structure9 sections

Indications and 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

Dosage and administration

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 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.

Label contents#

Full prescribing information#

Purposes

OTC - PURPOSE SECTION

Antihistamine

Cough Suppressant

Nasal Decongestant

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dexbrompheniramine Maleate 2 mg

Dextromethorphan Hydrobromide 15 mg

Phenylephrine Hydrochloride 7.5 mg

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

When using this product

OTC - WHEN USING SECTION

 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

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking sedatives or tranquilizers.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions? Comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AccutussdmAccutussdmAccu Tuss DM

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71208-10071208-100-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0dad71fd-ec86-1bb3-e063-6294a90a911af128cb2e-bac8-316d-e053-2995a90a52b62023-12-29WarningsExact identifier
spl set id: f128cb2e-bac8-316d-e053-2995a90a52b6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.