PUMPKIN SPICE COUGH DROPS- menthol lozenge

Pumpkin Spice Cough Drops by

Drug Labeling and Warnings

Pumpkin Spice Cough Drops by is a Otc medication manufactured, distributed, or labeled by Family Dollar, Bestco Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each drop)

Menthol 2.0 mg

PURPOSE

Purpose

Cough suppressant / Oral anesthetic

INDICATIONS & USAGE

Uses temporarily relieves:

cough as may occur with a cold

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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

ASK DOCTOR

Ask a doctor before use if you have:

persistent of chronic cough such as occurs with smoking, asthma, or emphysema

cough accompanied by excessive phlegm (mucus)

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

adults and children 5 years and over - allow 3 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 5 years - ask a doctor

OTHER SAFETY INFORMATION

Other information

10 calories per drop

INACTIVE INGREDIENT

Inactive ingredients: Corn starch, corn syrup, FD&C red no. 40, FD&C yellow no. 6, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUMPKIN SPICE COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-025
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	orange (Dark Orange)	Score	no score
Shape	OVAL	Size	17mm
Flavor	MENTHOL (Pumpkin Spice)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-025-30	30 in 1 BAG; Type 0: Not a Combination Product	07/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/18/2018

Labeler - Family Dollar (024472631)

Registrant - Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco Inc.		002149136	manufacture(55319-025)