Label: DRX CHOICE LONG ACTING COUGH- dextromethorphan hbr liquid
- NDC Code(s): 68163-742-04
- Packager: RARITAN PHARMACEUTICALS
- Category: HUMAN OTC DRUG LABEL
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 10, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each 10 mL)
- Purpose
- Uses
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Warnings
Do not use
if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- ▪
- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
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Directions
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- do not take more than 4 doses in a 24-hour period
- ▪
- measure only with dosing cup provided
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- keep dosing cup with product
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- mL = milliliter
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- this adult product is not intended for use in children under 12 years of age
age
dose
adults and children 12 years and over
10 mL every 6 to 8 hours
children under 12 years
do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
*Compare to the active ingredient in Adult Robitussin® Long-Acting Cough*
NDC 68163-742-04
DRx Choice
long-acting
cough
Dextromethorphan HBr (Cough Suppressant)
Relieves: Cough
8 HOURS RELIEF
No Added Alcohol
Sugar-Free
For Ages 12 & Over
4 FL OZ (118mL)
*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Adult Robitussin® Long-Acting Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.
IMPORTANT: Keep this carton for future reference for full labelling.
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick,
NJ 08816
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INGREDIENTS AND APPEARANCE
DRX CHOICE LONG ACTING COUGH
dextromethorphan hbr liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-742 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-742-04 1 in 1 BOX 04/24/2023 1 118 mL in 1 BOTTLE, PLASTIC; 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)