BRANTUSSIN DM- dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

BranTussin DM by

Drug Labeling and Warnings

BranTussin DM by is a Otc medication manufactured, distributed, or labeled by Brandywine Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Purposes

Antihistamine

Cough Suppressant

Nasal Decongestant

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 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.

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).

Package Label

INGREDIENTS AND APPEARANCE

BRANTUSSIN DM 
dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71321-700
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	7.5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71321-700-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/14/2022

Labeler - Brandywine Pharmaceuticals, LLC (080581956)