topco associates llc. tussin dm max drug facts

topco associates llc. tussin dm max drug facts
SPL v4
SPL
SPL Set ID e1118592-30ac-4505-9f38-c6d395c4cf5b
Route
oral
Published
Effective Date 2022-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (30 mg) doxylamine (12.5 mg)
Inactive Ingredients
anhydrous citric acid benzoic acid benzyl alcohol carboxymethylcellulose sodium, unspecified fd&c blue no. 1 fd&c red no. 40 glycerin menthol, unspecified form polyethylene glycol, unspecified propylene glycol water sodium benzoate sorbitol sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2019-05-02

Purpose

Cough suppressant Antihistamine

Description

Dextromethorphan HBr, USP 30 mg Doxylamine succinate, USP 12.5 mg


Medication Information

Uses
  • 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
Purpose

Cough suppressant Antihistamine

Directions
  • 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

age

dose

adults and children 12 years and over

20 mL every 6 hours

children under 12 years

do not use

Other Information
  • each 20 mL contains: sodium 11 mg
  • store at 20-25°C (68-77°F)
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

Description

Dextromethorphan HBr, USP 30 mg Doxylamine succinate, USP 12.5 mg

Principal Display Panel

TopCare® health

COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH NIGHTTIME COUGH DM ACTIVE INGREDIENTS

NIGHTTIME

Tussin DM Max

Nighttime Cough DM

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

MAXIMUM STRENGTH

RELIEVES:

• Cough

• Itchy Throat

• Runny Nose

Adult For Ages 12 & Over

4 FL OZ (118 mL)

RASPBERRY, BLACKBERRY & MENTHOL FLAVOR

Purposes

Cough suppressant

Antihistamine

Do Not Use
  • 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.
Questions Or Comments?

1-888-423-0139

When Using This Product
  • 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
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).

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Ask A Doctor Before Use If You Have
  • 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
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Uses
  • 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
Directions
  • 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

age

dose

adults and children 12 years and over

20 mL every 6 hours

children under 12 years

do not use

Other Information (Other information)
  • each 20 mL contains: sodium 11 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (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

Principal Display Panel

TopCare® health

COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH NIGHTTIME COUGH DM ACTIVE INGREDIENTS

NIGHTTIME

Tussin DM Max

Nighttime Cough DM

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

MAXIMUM STRENGTH

RELIEVES:

• Cough

• Itchy Throat

• Runny Nose

Adult For Ages 12 & Over

4 FL OZ (118 mL)

RASPBERRY, BLACKBERRY & MENTHOL FLAVOR

Purposes

Cough suppressant

Antihistamine

Do Not Use (Do not use)
  • 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.
Questions Or Comments? (Questions or comments?)

1-888-423-0139

When Using This Product (When using this product)
  • 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
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • 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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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