PEDIACARE CHILDRENS COUGH AND CONGESTION GRAPE- dextromethorphan hydrobromide and guaifenesin syrup 
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH

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.

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Pediacare® Children's Cough and Congestion Grape

Drug Facts

Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr, USP 5 mgCough suppressant
Guaifenesin, USP 100 mgExpectorant

Uses

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.

Directions

AGEDOSE
children under 4 yearsdo not use
children 4 to under 6 years5 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
adults and children 12 years and over20 mL every 4 hours

Other information

Inactive ingredients

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

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:

Dextromethorphan HBr, USP (5 mg per 5 mL)
Guaifenesin, USP (100 mg per 5 mL)

Non-Drowsy

Grape Flavor

4 FL OZ (118 mL)

Principal Display Panel - 118 mL Bottle Carton
PEDIACARE CHILDRENS COUGH AND CONGESTION GRAPE 
dextromethorphan hydrobromide and guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-992
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-992-011 in 1 CARTON01/03/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/03/2023
Labeler - RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH (061995007)

Revised: 12/2022
Document Id: caf8e909-90c3-4c17-aebd-6430d23ef53f
Set id: 9576723b-748c-45e7-bc0d-cc109b9f6735
Version: 1
Effective Time: 20221220
 
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH