DRX CHOICE CHILDRENS STUFFY NOSE AND CHEST CONGESTION- guaifenesin and phenylephrine hcl solution 
RARITAN PHARMACEUTICALS

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.

----------

DRx Choice Children's Stuffy Nose & Chest Congestion

Drug Facts

Active ingredients (in each 5 mL)

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 2.5 mg

Purposes

Expectorant
Nasal Decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
nasal congestion due to a cold
stuffy nose

Warnings

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

heart disease
high blood pressure
thyroid disease
diabetes
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with asthma

When using this product

 
do not use more than directed

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
symptoms do not get better within 7 days or occur with fever
cough lasts more than 7 days, comes back, or occurs with 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 right away 1-800-222-1222.

Directions

do not give more than 6 doses in any 24 hour period
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor

Age

Dose

Children 6 years to under 12 years

10 mL every 4 hours

Children 4 years to under 6 years

5 mL every 4 hours

Children under 4 years

do not use

Other information

each 5 mL contains: sodium 3 mg
very low sodium 
store at room temperature
do not refrigerate
dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum.

Questions or Comments?

1-866-467-2748

Package Label-Principal Display Panel 4 FL OZ (118 mL Bottle)

*Compare to the active ingredients in Children’s Mucinex® Stuffy Nose & Chest Congestion

NDC 68163-748-04

DRx Choice®

Children's

Stuffy Nose & Chest Congestion


Guaifenesin (Expectorant)
Phenylephrine HCl (Nasal Decongestant)

Relieves: Stuffy Nose, Chest congestion, Breaks Up Mucus

Dosage Cup Included

Mixed Berry Flavor

Naturally & artificially flavored

For Ages 4 & Over

4 FL OZ (118 mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT: Keep this carton for future reference on full labeling.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court. East Brunswick

NJ 08816


DRx Choice Children's Stuffy Nose and chest Congestion
DRX CHOICE CHILDRENS STUFFY NOSE AND CHEST CONGESTION 
guaifenesin and phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-748
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-748-041 in 1 CARTON04/24/2023
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 finalpart34104/24/2023
Labeler - RARITAN PHARMACEUTICALS (127602287)

Revised: 5/2023
Document Id: 7a3bb739-ff50-4d29-b270-d6b084906493
Set id: 7a3bb739-ff50-4d29-b270-d6b084906493
Version: 1
Effective Time: 20230511
 
RARITAN PHARMACEUTICALS