Leader tussin dm solution

Active ingredients (in each 10 ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes

Cough suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons 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

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

  • shake well before using
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children

12 years and over

10 mL

every 4 hours

children under 12 years

do not use

Other information

  • each 10 mL contains: sodium 7 mg
  • store at 20-25 C (68-77 F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Leader tussin dm solution- Dextromethorphan hbr, guaifenesin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70000-0300
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 20 mgin 10 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 400 mgin 10 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Carboxymethylcellulose sodium, unspecified form ( UNII: K679OBS311)
D&c red no. 33 ( UNII: 9DBA0SBB0L)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Menthol, unspecified form ( UNII: L7T10EIP3A)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Povidone, unspecified ( UNII: FZ989GH94E)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Saccharin sodium ( UNII: SB8ZUX40TY)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color RED (Opaque) Flavor CHERRY (Menthol)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Cardinal Health( 097537435)

Package/label principal display panel

Adult | Maximum Strength

Tussin DM

Cough + Chest Congestion DM

Dextromethorphan HBr Guaifenesin

Cough Suppressant Expectorant

Ages 12 Years and Over

Relieves:

Cough

Mucus

COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH COUGH + CHEST CONGESTION DM active ingredients

Non-Drowsy

100% Money Back Guarantee

4 FL OZ (118mL)