CHILDRENS MUCUS AND COUGH RELIEF- dextromethorphan hbr, guaifenesin liquid

ACTIVE INGREDIENTS (in each 5 mL)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
PURPOSE

Cough suppressant
Expectorant
USES
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
  - cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  - the impulse to cough to help your child get to sleep
  - the intensity of coughing
WARNING

.
DO NOT USE

in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
STOP USE AND ASK A DOCTOR IF
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness.
KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Age	Dose
children 6 years to under 12 years	5 mL-10 mL every 4 hours
children 4 years to under 6 years	2.5 mL - 5 mL every 4 hours
children under 4 years	do not use

OTHER INFORMATION
- each 5 mL contains: potassium 5 mg, sodium 5 mg
- store between 20 to 25°C (68 to 77°F)
- do not refrigerate
- dosing cup provided
INACTIVE INGREDIENTS

citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum
QUESTIONS COMMENTS?

call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est
PRINCIPAL DISPLAY PANEL

LEADER

NDC: 70000-0630-1

Children's Mucus & Cough Relief

Dextromethorphan HBr, 5mg

Guaifenesin 100 mg

cough Suppressant

Expectorant

Cherry Flavor

Ages 4+ Years

Controls Cough

Relieves Chest Congestion

Thins and Loosen Mucus

COMPARE TO CHILDREN'S MUCINEX® COUGH

active ingredients*
4 FL OZ (118mL)

CHILDRENS MUCUS AND COUGH RELIEF
dextromethorphan hbr, guaifenesin liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 70000-0630-1	1 in 1 CARTON	03/22/2023
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	03/22/2023

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(70000-0630)

Childrens Mucus and Cough Relief by