Honey Lemon Cough Drops: Package Insert and Label Information

HONEY LEMON COUGH DROPS- menthol lozenge
Bestco 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.

Active ingredient (in each drop)

Menthol 7.5 mg

Purpose

Cough suppressant / Oral anesthetic

Uses temporarily relieves:

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

Warnings

Sore throat warning: if sore throat is severe, persists for more then 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 accompanied 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

adults and children 5 years and over — dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

children under 5 years — ask a doctor

Other information

10 calories per drop

Inactive ingredients: Beta carotene (color), corn starch, corn syrup, eucalyptus oil, glycerin, honey, medium chain triglycerides, natural and artificial flavors, soybean oil, sucrose and water.

HONEY LEMON COUGH DROPS menthol lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52642-038 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 7.5 mg

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color yellow Score no score Shape OVAL Size 17mm Flavor HONEY (Honey and Lemon) Imprint Code B Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52642-038-30 30 LOZENGE in 1 BAG None

(click image for full-size original)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/23/2018

Labeler — Bestco Inc. (002149136)

Registrant — Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Operations
Bestco Inc.		002149136	manufacture (52642-038)

Revised: 11/2022 Bestco Inc.