HONEY LEMON COUGH DROPS- menthol lozenge

Honey Lemon Cough Drops by

Drug Labeling and Warnings

Honey Lemon Cough Drops by is a Otc medication manufactured, distributed, or labeled by Trader Joe's Company, Ragolds GmbH, Rudi Jahnke Süsswaren e.K.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each drop)

Menthol 6 mg

PURPOSE

Purpose

Cough suppressant/Oral anesthetic

INDICATIONS & USAGE

Uses temporarily relieves:

• cough as may occur with a cold
• cough associated with inhaled irritants
• occasional minor irritation and sore throat

WARNINGS

Warnings

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. These symptoms may be serious.

ASK DOCTOR

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• chronic cough that lasts such as occurs with smoking, asthma, or emphysema

STOP USE

Stop use and ask a 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• adults and children 5 years and older: dissolve drop slowly in the mouth. May be repeated every two hours as needed or as directed by a doctor
• children under 5 years: ask a doctor

STORAGE AND HANDLING

Other information

• store in a cool, dry place
• contains wheat
  

INACTIVE INGREDIENT

Inactive ingredients beta carotene, citric acid, eucalyptus oil, glucose (corn, wheat) syrup, herbal extract (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme); honey, lemon juice concentrate, natural flavor, natural lime flavor, sugar, water.

SPL UNCLASSIFIED SECTION

If your day's been marred by a cough or sore throat, we hope Trader Joe's Honey Lemon Cough Drops can provide a little bit of brightness. They're made with menthol, which helps to naturally ease the discomfort that comes with coughs and sore throats. And, with 4% real acacia honey, they also happen to be tasty.

DIST. & SOLD EXCLUSIVELY BY:

TRADER JOE'S

MONROVIA, CA 91016

PRODUCT OF GERMANY

PRINCIPAL DISPLAY PANEL

TRADER JOE'S®

HONEY LEMON

COUGH DROPS

MENTHOLCOUGH SUPPRESSANTORAL ANESTHETIC

COUGH RELIEF

SOOTHES SORE THROATS

15 DROPS

INGREDIENTS AND APPEARANCE

HONEY LEMON COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71270-581
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
PEPPERMINT (UNII: V95R5KMY2B)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
WATER (UNII: 059QF0KO0R)
CORN SYRUP (UNII: 9G5L16BK6N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MELISSA OFFICINALIS (UNII: YF70189L0N)
SAGE (UNII: 065C5D077J)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MALVA NEGLECTA WHOLE (UNII: S0QQA41760)
HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)
HONEY (UNII: Y9H1V576FH)
LEMON JUICE (UNII: AGN709ANTJ)
THYME (UNII: CW657OBU4N)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
HOREHOUND (UNII: K08036XEJV)

Product Characteristics
Color	yellow (Honey Colored)	Score	no score
Shape	OVAL	Size	25mm
Flavor	HONEY (Honey & Lemon) , LEMON (Honey & Lemon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71270-581-15	15 in 1 BAG; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2018

Labeler - Trader Joe's Company (006226666)

Registrant - Ragolds GmbH (506640254)

Establishment
Name	Address	ID/FEI	Business Operations
Jahnke Süßwaren GmbH		314278048	manufacture(71270-581)