SF MENTHOL COUGH DROP- menthol lozenge

SF menthol cough drop by

Drug Labeling and Warnings

SF menthol cough drop by is a Otc medication manufactured, distributed, or labeled by Super Valu, Bestco, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each drop)

Menthol 5.8mg

PURPOSE

Purposes

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, headaches, 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 or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phegm (mucus)

STOP USE

Stop use and consult 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 - 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 SAFETY INFORMATION

Other information

• 6 calories per drop
• Excess consumption may cause a laxative effect.

INACTIVE INGREDIENT

Inactive Ingredients: Acesulfame potassium, corn starch, eucalyptus oil, FD&C blue no 1, FD&C red no. 40, glycerin, gum arabic, isomalt, maltitol syrup, medium chain triglycerides, natural and artificial flavors, potassium sorbate, soybean oil, sucralose and water.

QUESTIONS

Questions? Or to report an adverse event call 1-877-932-7948.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SF MENTHOL COUGH DROP 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-027
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.8 mg

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

Product Characteristics
Color	blue (Light blue with flakes)	Score	score with uneven pieces
Shape	OVAL	Size	16mm
Flavor	MENTHOL	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-027-25	25 in 1 BAG; Type 0: Not a Combination Product	06/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/18/2014

Labeler - Super Valu (006961411)

Registrant - Bestco, Inc (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco, Inc		002149136	manufacture(41163-027)