Label: DRX CHOICE SORE THROAT MENTHOL FLAVOR- phenol spray
- NDC Code(s): 68163-307-06
- Packager: RARITAN PHARMACEUTICALS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 2, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by doctor.
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Directions
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- Adults and children 12 year of age and older:
Apply to affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out.
Use every 2 hours or as directed by a doctor or dentist
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- Children under 12 years of age: Should be supervised in use of this product.
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- Children under 6 years of age: Ask a doctor or dentist
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
DRx Choice®
NDC# 68163-307-06
*Compare to the active ingredient in Chloraseptic®
Sore throat spray
Phenol/Oral Pain Reliever
- •
- Fast Acting
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- Numbs on Contact
SUGAR-FREE
ASPIRIN-FREE
Menthol Flavor
Naturally and Artificially Flavored
6 FL OZ. (177 mL)
*This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®.
TAMPER EVIDENT: Do not use if imprinted shrink band is broken or torn.
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INGREDIENTS AND APPEARANCE
DRX CHOICE SORE THROAT MENTHOL FLAVOR
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-307 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 1.4 g in 100 mL Inactive Ingredients Ingredient Name Strength FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color GREEN (clear) Score Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-307-06 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/17/2022 Labeler - RARITAN PHARMACEUTICALS INC (127602287)
