Label: FREEGELLS COUGH DROPS MENTHOL CHERRY 80CT- menthol lozenge
- NDC Code(s): 83002-002-01
- Packager: R.L. ALBERT & SON, INC
- 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 June 22, 2023
If you are a consumer or patient please visit this version.
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- Active ingredient
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Warning
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. if sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.
Ask a doctor before use if you have :
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanined by excessive phlegm (mucus)
stop use and ask doctor if
- cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- sore throat is severe, or irritation, pain or redness lasts or worsens
- sore mouth does not improve in 7 days
If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Product label
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INGREDIENTS AND APPEARANCE
FREEGELLS COUGH DROPS MENTHOL CHERRY 80CT
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83002-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.8 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) CORN SYRUP (UNII: 9G5L16BK6N) EUCALYPTOL (UNII: RV6J6604TK) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color red Score no score Shape OVAL Size 20mm Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83002-002-01 6 in 1 CARTON 06/21/2023 1 80 in 1 BAG; 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 06/21/2023 Labeler - R.L. ALBERT & SON, INC (005900899)
