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

DRx Choice Childrens Stuffy Nose and Chest Congestion by

Drug Labeling and Warnings

DRx Choice Childrens Stuffy Nose and Chest Congestion by is a Otc medication manufactured, distributed, or labeled by RARITAN PHARMACEUTICALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 usein 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-748
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-748-04	1 in 1 CARTON	04/24/2023
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/24/2023

Labeler - RARITAN PHARMACEUTICALS (127602287)