TOPCARE TUSSIN DM MAX- dextromethorphan hydrobromide, doxylamine succinate solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)
Available from:
Topco Associates LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cough suppressant Antihistamine
Authorization status:
OTC monograph final
Authorization number:
36800-788-26

TOPCARE TUSSIN DM MAX- dextromethorphan hydrobromide, doxylamine

succinate solution

Topco Associates LLC

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.

----------

Topco Associates LLC. Tussin DM Max Drug Facts

Active ingredients (in each 20 mL)

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Purpos es

Cough suppressant

Antihistamine

Us es

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

controls the impulse to cough to help you sleep

to make a child sleepy

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.

trouble urinating due to an enlarged prostate gland

glaucoma

cough that occurs with too much phlegm (mucus)

a breathing problem such as emphysema or chronic bronchitis

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

taking sedatives or tranquilizers

When using this product

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

A persistent cough may be a sign of a serious condition.

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 (1-800-222-1222).

Directions

dose

adults and children 12 years and over

20 mL every 6 hours

children under 12 years

do not use

Other information

Inactive ingredients

anhydrous citric acid, benzoic acid, benzyl alcohol, carboxymethylcellulose sodium, FD&C blue #1,

FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water,

sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-888-423-0139

do not use more than directed

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

measure only with dosing cup provided

keep dosing cup with product

mL = milliliter

do not take more than 4 doses in any 24-hour period

this adult product is not intended for use in children under 12 years of age

each 20 mL contains: sodium 11 mg

store at 20-25°C (68-77°F)

Principal Display Panel

COMPARE TO ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM ACTIVE

INGREDIENTS

SEE NEW DOSING

NIGHTTIME

Tussin DM Max

Nighttime Cough DM

COUGH SUPPRESSANT–DEXTROMETHORPHAN HBr

ANTIHISTAMINE–DOXYLAMINE SUCCINATE

MAXIMUM STRENGTH

OUR PHARMACISTS RECOMMEND

RELIEVES:

Cough

Itchy Throat

Runny Nose

Adult

For Ages 12 & Over

4 FL OZ (118 mL)

RASPBERRY, BLACKBERRY & MENTHOL FLAVOR

TOPCARE TUSSIN DM MAX

dextromethorphan hydrobromide, doxylamine succinate solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -78 8

Route of Administration

ORAL

Active Ingredient/Active Moiety

Topco Associates LLC

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

30 mg

in 20 mL

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE -

UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

12.5 mg

in 20 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GLYCERIN (UNII: PDC6 A3C0 OX)

MENTHO L (UNII: L7T10 EIP3A)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

FRUIT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:36 8 0 0 -78 8 -26

1 in 1 CARTON

0 5/0 2/20 19

1

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 5/0 2/20 19

Labeler -

T opco Associates LLC (006935977)

Revised: 5/2019

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