Label: NICE SORE THROAT HONEY LEMON- phenol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 69626-0077-6 - Packager: Leosons Overseas Corp
- 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 December 21, 2020
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- Drug Facts
- Active Ingredient & Purposes
- 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 doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
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Directions
- apply to the affected area
- 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
age dose adults and children 12 years of age and older for each application, spray 5 times children 3 to under 12 years should be supervised in use of this product
for each application, spray 3 times
children under 3 years of age consult a doctor or dentist - Other Information
- Tamper Evident:
- Inactive ingredients
- QUESTIONS?
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INGREDIENTS AND APPEARANCE
NICE SORE THROAT HONEY LEMON
phenol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69626-0077 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 177 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CARAMEL (UNII: T9D99G2B1R) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color yellow Score Shape Size Flavor HONEY (Honey Lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69626-0077-6 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/07/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/07/2014 Labeler - Leosons Overseas Corp (148605470)