SEVERE THROAT DROPS- menthol ice pastille

Severe Throat Drops by

Drug Labeling and Warnings

Severe Throat Drops by is a Otc medication manufactured, distributed, or labeled by Target Corporation Inc., Boston Nutraceutical Science SL, Boston Nutraceutical Production SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient 20 mg

Oral anesthetic

PURPOSE

Uses temporarily relieves ocassional minor irritation and pain due toL

• Sore throat
• Sore mouth

INDICATIONS & USAGE

Uses temporarily relieves ocassional minor irritation and pain due to:

• Sore throat
• Sore mouth

WARNINGS

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

ASK DOCTOR

Ask a doctor before use if you have

• a severe throat accompanied by difficulty in breathing or that last more than 2 days
• a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

STOP USE

Stop use and consult a doctor if

• sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children.

OVERDOSAGE

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
• Children under 12 years and under do not use

OTHER SAFETY INFORMATION

• Store in a cool and dry place

INACTIVE INGREDIENT

eucalytus oil, FD&C blue No.1, glucose syrup, gum arabic, sucrose

QUESTIONS

Questions? or to report and adverse event call: 1-800-910-68-74

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEVERE THROAT DROPS 
menthol ice pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82442-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTOL (UNII: RV6J6604TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ACACIA (UNII: 5C5403N26O)
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	OVAL	Size	25mm
Flavor	MENTHOL	Imprint Code	None
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82442-201-01	45 in 1 BAG; Type 0: Not a Combination Product	05/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/15/2024

Labeler - Target Corporation Inc. (006961700)

Registrant - Boston Nutraceutical Science SL (466061824)

Establishment
Name	Address	ID/FEI	Business Operations
Boston Nutraceutical Production SL		468121064	manufacture(82442-201) , label(82442-201) , pack(82442-201)