OTC Medication Information: BestHealth Herbal Cough Drops

BESTHEALTH HERBAL COUGH DROPS- menthol lozenge
Bestco LLC

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 4.8 mg

Purpose

Cough suppressant / Oral anesthetic

Uses temporarily relieves:

• cough as may occur with a cold or inhaled irritants
• minor sore throat

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. 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 6 years and over — allow 2 drops to dissolve slowly in mouth one at a time. May be repeated every two hours as necessary or as directed by a doctor.

children under 6 years — ask a doctor

Other information

• 17 calories per drop

Inactive ingredients: Caramel (color), corn starch, glucose syrup, glycerin, herbal extract blend (Elderflower, Horehound, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), medium chain triglycerides, natural flavors, soybean oil, sucrose, water.

Questions? Or to report an adverse event call 1-800-245-2898. Monday — Friday, 9AM to 4PM EST

BESTHEALTH HERBAL COUGH DROPS menthol lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52642-050 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 4.8 mg

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color brown Score no score Shape OVAL Size 17mm Flavor PEPPERMINT (Herbal & Peppermint) Imprint Code B Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52642-050-18 18 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 03/31/2021

Labeler — Bestco LLC (002149136)

Registrant — Bestco LLC (002149136)

Establishment
Name	Address	ID/FEI	Operations
Bestco LLC		002149136	manufacture (52642-050)

Revised: 11/2022 Bestco LLC