DRx Choice Childrens Stuffy Nose and Chest Congestion — v3

DRx Choice Childrens Stuffy Nose and Chest Congestion

8 Views

Version

v3

Effective date

September 29, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
3fef0ee0-c60c-a9de-e063-6394a90a99d6
Set ID
7a3bb739-ff50-4d29-b270-d6b084906493
Application numbers
M012
Product NDCs
68163-748
Package NDCs
68163-748-04
Original packager NDCs
—

Names & Manufacturers

Brand names
DRx Choice Childrens Stuffy Nose and Chest Congestion
Generic names
GUAIFENESIN AND PHENYLEPHRINE HCL
Manufacturer names
RARITAN PHARMACEUTICALS
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions [PE]
Pharmacologic class (EPC)
Expectorant [EPC]
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
N0000008867, N0000009560, N0000193956
RxCUI
—
UNII
04JA59TNSJ, 495W7451VQ
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Drug Facts Active ingredients (in each 5 mL) Guaifenesin, USP 100 mg Phenylephrine HCl, USP 2.5 mg
Ask Doctor (1)

Sequence 1

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
Dosage And Administration (1)

Sequence 1

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
Dosage And Administration Table (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum.
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

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.
Package Label Principal Display Panel (1)

Sequence 1

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
Package Label Principal Display Panel Table (2)

Sequence 1

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

Sequence 2

IMPORTANT:Keep this carton for future reference on full labeling.
Purpose (1)

Sequence 1

Purposes Expectorant Nasal Decongestant
Questions (1)

Sequence 1

Questions or Comments? 1-866-467-2748
Spl Product Data Elements (1)

Sequence 1

DRx Choice Childrens Stuffy Nose and Chest Congestion Guaifenesin and Phenylephrine Hcl ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE SORBITOL SUCRALOSE XANTHAN GUM GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE
Stop Use (1)

Sequence 1

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.
Storage And Handling (1)

Sequence 1

Other information each 5 mL contains : sodium 3 mg very low sodium store at room temperature do not refrigerate dosing cup provided
Warnings (1)

Sequence 1

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.
When Using (1)

Sequence 1

When using this product do not use more than directed

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['DRx Choice Childrens Stuffy Nose and Chest Congestion'],
 'generic_name': ['GUAIFENESIN AND PHENYLEPHRINE HCL'],
 'is_original_packager': [True],
 'manufacturer_name': ['RARITAN PHARMACEUTICALS'],
 'nui': ['N0000193956', 'N0000008867', 'N0000009560'],
 'package_ndc': ['68163-748-04'],
 'pharm_class_epc': ['Expectorant [EPC]'],
 'pharm_class_pe': ['Decreased Respiratory Secretion Viscosity [PE]',
                    'Increased Respiratory Secretions [PE]'],
 'product_ndc': ['68163-748'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['3fef0ee0-c60c-a9de-e063-6394a90a99d6'],
 'spl_set_id': ['7a3bb739-ff50-4d29-b270-d6b084906493'],
 'substance_name': ['GUAIFENESIN', 'PHENYLEPHRINE HYDROCHLORIDE'],
 'unii': ['495W7451VQ', '04JA59TNSJ']}