Xlear Cough Drops (Green Apple): Package Insert and Label Information

XLEAR COUGH DROPS (GREEN APPLE)- 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.

4.0mg of Menthol (per drop)

Cough Suppressant / Oral Anesthetic

Temporarily soothes an irritated or sore throat

Alfalfa, Isomalt, Malic Acid, Natural Apple Flavor, Stevia, Titanium Dioxide, Xytitol

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 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.

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

label
(click image for full-size original)

XLEAR COUGH DROPS (GREEN APPLE)
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:27017-021
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 4 mg
Inactive Ingredients
Ingredient Name Strength
XYLITOL
MALIC ACID
STEVIA LEAF
ISOMALT
TITANIUM DIOXIDE
ALFALFA
Product Characteristics
Color green Score score with uneven pieces
Shape ROUND Size 22mm
Flavor APPLE Imprint Code none
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27017-021-01 30 LOZENGE in 1 BOX None
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 Operations
Primrose Candy Company 005086855 manufacture (27017-021)

Revised: 01/2020 Xlear Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.