Label: DRX CHOICE CHILDRENS STUFFY NOSE AND CHEST CONGESTION- guaifenesin and phenylephrine hcl solution
- NDC Code(s): 68163-748-04
- Packager: RARITAN PHARMACEUTICALS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purposes
- Uses
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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
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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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
- Inactive ingredients
- Questions or Comments?
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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
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INGREDIENTS AND APPEARANCE
DRX CHOICE CHILDRENS STUFFY NOSE AND CHEST CONGESTION
guaifenesin and phenylephrine hcl solutionProduct 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 final part341 04/24/2023 Labeler - RARITAN PHARMACEUTICALS (127602287)