XLEAR COUGH DROPS (HONEY LEMON)- menthol lozenge

Xlear Cough Drops (Honey Lemon) by

Drug Labeling and Warnings

Xlear Cough Drops (Honey Lemon) by is a Otc medication manufactured, distributed, or labeled by Xlear Inc., Primrose Candy Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

4.0 mg of Menthol (per drop)

PURPOSE

Cough Suppressant / Oral Anesthetic

INDICATIONS & USAGE

Temporarily soothes an irritated or sore throat

DOSAGE & ADMINISTRATION

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.

WARNINGS

If sore throat is severe, persists for more than 2 days, 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

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

cinnamon bark oil, clove bud oil, eucalyptus radiata leaf oil, isomalt, lemon peel oil, pectin, peppermint aerial parts oil, rosemary leaf oil, stevia leaf extract, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XLEAR COUGH DROPS (HONEY LEMON) 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27017-022
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 mg

Inactive Ingredients
Ingredient Name	Strength
CURCUMA LONGA LEAF (UNII: H2HC4RY52C)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MALIC ACID (UNII: 817L1N4CKP)
STEVIA LEAF (UNII: 6TC6NN0876)
XYLITOL (UNII: VCQ006KQ1E)
ISOMALT (UNII: S870P55O2W)
HONEY (UNII: Y9H1V576FH)

Product Characteristics
Color	yellow	Score	score with uneven pieces
Shape	ROUND	Size	22mm
Flavor	HONEY (Lemon)	Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27017-022-01	30 in 1 BOX; Type 0: Not a Combination Product	12/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/12/2019

Labeler - Xlear Inc. (839884058)

Establishment
Name	Address	ID/FEI	Business Operations
Primrose Candy Company		005086855	manufacture(27017-022)