Label: DRX CHOICE MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT- acetaminophen, dextromethorphan hbr solution
- NDC Code(s): 68163-749-08
- 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
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 6 doses in any 24 hours period, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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Do not use
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- 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.
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product do not use more than directed.
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
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- do not take more than 6 doses in any 24-hour period
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- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
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- 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
20 mL every 4 hours
children under 12 years
do not use
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to active ingredients in Robitussin® Maximum Strength Severe Cough + Sore Throat CF MAX*
NDC 68163-749-08
DRx Choice®
maximum strength
SEVERE
cough + sore throat
Acetaminophen (Pain reliever / Fever reducer)
Dextromethorphan HBr (Cough Suppressant)
Relieves:
- •
- Cough
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- Sore throat pain
For Ages 12 Years & over
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- No added Sugar
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- No added Alcohol
Strong Cooling Liquid
8 FL OZ (237 mL)
*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Robitussin® Maximum Strength Severe Cough + Sore Throat CF MAX.
Maximum Strength claim based on maximum levels of active ingredients per dose.
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 MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT
acetaminophen, dextromethorphan hbr solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-749 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-749-08 1 in 1 CARTON 04/24/2023 1 237 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)