XLEAR COUGH DROPS (BLACK CHERRY)- menthol lozenge 
Xlear Inc.

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.

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Xlear Cough Drops (Black Cherry)

4.0 mg of menthol (per drop)

Cough Suppressant / Oral Anesthetic

Temporarily soothes an irritated or sore throat

Bett Juice, Isomalt, Malic Acid, Natural Cherry Flavor, Stevia, Titanium Dioxide, Xylitol

Adults and children over five - Slowly dissolve one drop every two hours as needed or as directed by a physician. Children under five - Consult your physician.

If sore throat is severe, persists for more than 2days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore throat symptoms do not improve in 7 days, see your doctor promptly.

Keep out of reach of children.

Allergen Information: Mfg. in a facility that processes dairy, peanut, almond, walmut, nutmeg, pecan and soy protein.

label

XLEAR COUGH DROPS (BLACK CHERRY) 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27017-020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 mg
Inactive Ingredients
Ingredient NameStrength
MALIC ACID (UNII: 817L1N4CKP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BEET JUICE (UNII: IOZ32L9H3O)  
XYLITOL (UNII: VCQ006KQ1E)  
STEVIA LEAF (UNII: 6TC6NN0876)  
ISOMALT (UNII: S870P55O2W)  
Product Characteristics
ColorpinkScorescore with uneven pieces
ShapeROUNDSize22mm
FlavorCHERRY (Black Cherry) Imprint Code none
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27017-020-0130 in 1 BOX; Type 0: Not a Combination Product12/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/12/2019
Labeler - Xlear Inc. (839884058)
Establishment
NameAddressID/FEIBusiness Operations
Primrose Candy Company005086855manufacture(27017-020)

Revised: 1/2023
Document Id: f1ec6441-50ae-7764-e053-2995a90a851c
Set id: 9985caff-9b43-3e74-e053-2995a90a1da4
Version: 2
Effective Time: 20230110
 
Xlear Inc.