Label: NICE HONEY LEMON COUGH DROPS- menthol lozenge
- NDC Code(s): 69626-0045-4
- Packager: Leosons International
- 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 December 30, 2022
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- Drug Facts
- Active Ingredient & Purposes
- Uses
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Warnings
Warnings
Ask a doctor before use if you have
- chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor before use if you have
- chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask doctor if
- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
- sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
- sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens
- Directions
- Inactive Ingredients
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- Package Label
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INGREDIENTS AND APPEARANCE
NICE HONEY LEMON COUGH DROPS
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69626-0045 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EUCALYPTUS OIL (UNII: 2R04ONI662) SODIUM CITRATE (UNII: 1Q73Q2JULR) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASCORBIC ACID (UNII: PQ6CK8PD0R) CARAMEL (UNII: T9D99G2B1R) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ISOMALT (UNII: S870P55O2W) Product Characteristics Color yellow Score no score Shape ROUND Size 17mm Flavor HONEY (Honey and Lemon) Imprint Code N Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69626-0045-4 24 in 1 BLISTER PACK; Type 0: Not a Combination Product 11/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/08/2019 Labeler - Leosons International (148605470)