Drx Choice Children's Stuffy Nose & Chest Congestion

Drx Choice Children's Stuffy Nose & Chest Congestion
SPL v3
SPL
SPL Set ID 7a3bb739-ff50-4d29-b270-d6b084906493
Route
ORAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Glycerin Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-24

Description

Active ingredients (in each 5 mL) Guaifenesin, USP 100 mg Phenylephrine HCl, USP 2.5 mg

Purpose

Expectorant Nasal Decongestant


Medication Information

Purpose

Expectorant Nasal Decongestant

Description

Active ingredients (in each 5 mL) Guaifenesin, USP 100 mg Phenylephrine HCl, USP 2.5 mg

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
Purposes

Expectorant

Nasal Decongestant

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.

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

Drug Facts

Active ingredients (in each 5 mL)

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 2.5 mg

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

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.

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
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




Structured Label Content

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
Purposes

Expectorant

Nasal Decongestant

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.

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

Drug Facts

Active ingredients (in each 5 mL)

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 2.5 mg

Other Information (Other information)
  • each 5 mL contains: sodium 3 mg
  • very low sodium 
  • store at room temperature
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (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? (Questions or Comments?)

1-866-467-2748

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (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. (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.

Ask A Doctor Before Use If the Child Has (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
Package Label Principal Display Panel 4 Fl Oz (118 Ml Bottle) (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




Advanced Ingredient Data


Raw Label Data

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