PEDIACARE CHILDRENS COUGH AND CONGESTION GRAPE- dextromethorphan hydrobromide and guaifenesin syrup

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients (in each 5 mL) Purposes

Dextromethorphan HBr, USP 5 mg Cough suppressant

Guaifenesin, USP 100 mg 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 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
- 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 more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs 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.

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr, USP 5 mg	Cough suppressant
Guaifenesin, USP 100 mg	Expectorant

Directions

AGE	DOSE
children under 4 years	do not use
children 4 to under 6 years	5 mL every 4 hours
children 6 to under 12 years	10 mL every 4 hours
adults and children 12 years and over	20 mL every 4 hours

Other information
- store at 20-25°C (68-77°F)
- do not refrigerate
- alcohol-free
Inactive ingredients

acesulfame potassium, citric acid anhydrous, glycerin, flavor, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin
SPL UNCLASSIFIED SECTION

Distributed by
CrossingWell Consumer Health
PO Box 440
Cornwall, NY 12518
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Fast Acting

Pedia
Care®

100% dedicated
to kids™

4 Years & Up

COUGH &
CONGESTION

Relieves:
- Congestion & Mucus
- Cough
Dextromethorphan HBr, USP (5 mg per 5 mL)
Guaifenesin, USP (100 mg per 5 mL)

Non-Drowsy

Grape Flavor

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

PEDIACARE CHILDRENS COUGH AND CONGESTION GRAPE
dextromethorphan hydrobromide and guaifenesin syrup

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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 52412-992-01	1 in 1 CARTON	01/03/2023
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	01/03/2023

Labeler - RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH (061995007)

Pediacare Childrens Cough and Congestion Grape by